510(k) Submissions Written by Kamm & Associates: fda-consultant.com

(Over 200 successful clearances)

Company Name

Device Name

510(k)

Number

Grass-Astromed

EEG Software

K963669

Yoshida (Japan)

Panoramic Dental X-Ray

K965072

Snap Laboratories

Apnea Monitor

K971184

Amplifon (Italy)

Evoked Potential Monitor

K971740

Amplifon (Italy)

Audiometer

K971747

Estrad BV (Netherlands)

Periodontal Depth Probe, Electronic

K972642

Amplifon (Italy)

Audiometer

K972862

Amplifon (Italy)

Evoked Potential Monitor

K972959

Ortivus (Sweden)

ECG Monitor, Ambulance

K973318

Amplifon (Italy)

Auditory Impedance Tester

K974235

Lorac

Acupuncture Needles

K974616

Sam Technologies

EEG/MRI Software

K980477

NidaCon International (Sweden)

Sperm Separation Medium

K980814

Amplifon (Italy)

Audiometers

K983712

Amplifon (Italy)

Audiometers

K983915

Snap Laboratories

Ventilatory  Effort Recorder

K984169

NidaCon International (Sweden)

Sperm Separation Medium

K984172

ElectraMed

Measuring Ergometer

K990813

Intercontinental New Technologies

Breathing Exercise Device

K992256

Ljungberg-Kogel (Sweden)

Bloodbank Scale/Mixer

BK990013

Snap Laboratories

Ventilatory  Effort Recorder

K992322

Amplifon (Italy)

Auditory Impedance Meter

K992370

IODP (France)

3D Ultrasound Software

K011095

Sewoon Medical Device (Korea)

Silicone Foley Catheters

K013276

E.S.W.L. Products, Inc

Extracorporeal Lithotripter

K013471

CANČ S.r.l.  (Italy)

Ambulatory Infusion Pump

K013776

CANČ S.r.l.  (Italy)

Insulin Infusion Pump

K013807

CANČ S.r.l.  (Italy)

Ambulatory Infusion Pump for Pain Management

K013822

CANČ S.r.l.  (Italy)

Ambulatory Infusion Pump

K013840

CANČ S.r.l.  (Italy)

Ambulatory Infusion Pump

K013855

Machnet BV (Netherlands)

MRI Coil

K013985

PadPro LLC

Disposable Defibrillator Electrode

K014209 (Special)

Vector Research and Development

High-speed Dental Handpieces

K020113

Capsule Technologie (France)

Modification to Data Acquisition Software

K020197 (Special)

PadPro LLC

Disposable Defibrillator Electrode

K020203

PadPro LLC

Disposable Defibrillator Electrode

K020288 (Special)

Machnet BV (Netherlands)

Breast Biopsy Intervention Aid for MRI

K020289

Sedecal (Spain)

Portable X-Ray System

K020436

Evans Medical, Inc

Winged Subcutaneous Infusion Set

K020530

PadPro LLC

Disposable Defibrillator Electrode

K020743

Toei Electric Company Limited (Japan)

Dental Root Apex Locator

K022020 (Special)

Nidacon AB ( Sweden )

Sperm Re-suspension Medium  for Assisted Reproductive Technology

K022443

Health Care Manufacturing, Inc.

General Purpose Radiographic X-Ray System

K022667

Health Care Manufacturing, Inc.

Chiropractic X-Ray System

K022737

Nidacon AB (Sweden)

Sperm Cryopreservative for Assisted Reproductive Technology

K023206

Meridian Co. Ltd. (Korea)

Photoelectric Plethysmograph

K023238

Jeil Medical Corporation (Korea)

LeForte System Bone Plates

K023360

Jeil Medical Corporation (Korea)

LeForte System Bone Screws

K023365

BioSpace Corp. Ltd. (Korea)

Body Composition Analyzer

K023478

Analyticon Biotechnologies AG (Germany)

Urine Test Strips

K023885

Ralco S.r.l. (Italy)

X-Ray Collimator

K030487

SEZ Corporation (Korea)

Safety Syringe

K031163

Ethox, Inc.

Blood Pressure Cuff Cover

K031195

GS Technology Co., Ltd. (Korea)

Electronic Stethoscope

K031446

Nihon Seimitsu Sokki Co., Ltd. (Japan)

Combination Blood Pressure Meter/Body Composition Analyzer

K031582

Carematix, Inc

Home Wellness System

K031840

KaVo America Corporation

Dental Polishing Agent

K031868 (Special)

Med Systems Inc

Chest Percussor

K031876

Amplaid (Italy)

Screening Auditory Impedance Tester

K031978 (Special)

KaVo America Corporation

Zirconium Oxide Dental Device

K032081 (Special)

Capsule Technologie (France)

Data Acquisition Software

 K032142 (Special)

Remco Italia S.p.A. (Italy)

Electrocardiograph with Analysis

K032200  (Abbreviated)

OMI Manufacturing Pty Ltd (Australia)

Safety Scalpel

K032242

Livingston Products, Inc.

Breast Compression Paddle

K033202

The Buzz Group LLC

Digital Blood Pressure Monitor

K033216

KaVo America Corporation

Zirconium Oxide Dental Device

K033221 (Special)

Medlink Imaging

Digital X-Ray System

K033599 (Abbreviated)

Jeil Medical Corporation (Korea)

Titanium Screw Implants, Orthodontic

K033767

Meridian Co. (Korea)

Laser for pain therapy

K034009

Mikasa (Japan)/MinXray

Portable X-Ray

K040046 (Special)

Nissei (Japan)

Digital Blood Pressure Monitor

 K040309
Cleared in 15 days!  (Special)

KHN Solutions LLC

Digital Breath Alcohol Test System

K041334
The FIRST 510(k) for this kind of device.

Tympany

Combination -Pure tone and speech audiometer, impedance audiometer, and distortion product otoacoustic emissions analyzer

K041853

CANČ S.r.l.  (Italy)

Ambulatory Infusion Pump

K042085 (Special)

Sedecal (Spain)

Digital X-Ray System

K042361 (Special)

Vatech

Digital Dental X-Ray Sensor

K042372

KaVo Dental Corporation

Subgingival Dental Calculus Detector (Laser)

K042394

EDDA Technology, Inc.

PACS System

K042408
Traditional 510(k) cleared in 39 days.

BioSpace Corp. Ltd. (Korea)

Body Composition Analyzer

K042528

KaVo America Corporation

Dental Handpiece- Airbrush

K042872 (Special)

Sedecal (Spain)

Digital X-Ray System

K042876 (Special)

Q3 Innovations, LLC

Digital Breath Alcohol Test System

K043188

Medexel (Korea)

Safety Syringe

K043419

Panoramic Corp

Panoramic Dental X-Ray

K043557
Cleared in 17 days
(Special)

FIM Medical

Spirometer Filter

K050424

Jeil Medical Corporation (Korea)

Dental Bone Fixation System

K050669

KaVo Dental Corporation

Dental Video System

K050744

CRS Medical

Endoluminal Brush

K050889

VitalCare Group, Inc.

IV Administration Set

K050906

eemagine Medical Imaging Solutions GmbH (Germany)

EEG and Evoked Potential Hardware and Software

K051825

KaVo Dental Corporation

Laser Caries Detector

K051909

Heeyoung Co. Ltd (Korea)

LCD Monitors for Cardiology

K052120

Connectables LLC

Breath Alcohol Tester

K052448

Shanghai Fimet (China) 

Dental Chair with Operative Unit

K052470

Beijing Wangdong Medical Equipment (China)

Diagnostic X-Ray System

K052541

Biospace (Korea)

Body Composition Monitors

K052646

Mikasa (Japan)/MinXray

Portable X-Ray

K052721 (Special)

Cardiocom LLC

 Non-invasive automated blood pressure meter.

K053303 and K053304

Waldmann Lighting

Surgical Lamp

K053364

Scorpion (France)

Ultrasonic Scaling Inserts

K053578

Diagnostic Devices Inc.

Blood Glucose Meter

K053593

KaVo Dental Corporation

Subgingival Dental Calculus Detector (Laser)

K060080 (Special)

KaVo Dental Corporation

Dental Imaging System

K060178

Implant Logic Systems

Dental Implant Planning Software

K060267

B&L Biotech Co. Ltd (Korea)

Gutta Percha Gun

K060347

MBL International Corporation (Japan)

ELISA Kit

K060431

Diagnostic Devices Inc.

Blood Glucose Meter

K060467

Mikasa (Japan)/MinXray

Podiatric X-Ray

K060566  (Special)

OMI (Australia)

Safety Syringe

K060971

Medical Devices/Padpro

Defibrillator Tester

K061606

Sedecal (Spain)

Diagnostic X-Ray System

K062335 (Special)

Pishon High Tech Co., Ltd (Korea) 

Electronic Stethoscope

K062481

RMI, Incl.

Breath Alcohol Detector

K062545

Resource Management International LLC

Breath Alcohol Detector

K062545

BioSpace Corp. Ltd. (Korea)

Body Composition Analyzer

K062603

Virtual Imaging

Mobile Digital X-Ray System

K063262

GE Medical

Digital X-Ray System

K063283

Daejin (Korea)

Insulin Syringe

K063348

Daejin (Korea)

Insulin Pen Needle

K063466

Amann Girrbach (Austria)

Dental Material

K063511

Yoshida (Japan)

Dental CT

K063622

KaVo Dental Corporation

Dental Material

K063624

Synvasive Technology Inc

Knee Implant Adjustment Tool

K070108

Eemagine Medical Imaging Solutions (Germany)

EEG Software

K070358

Virtual Imaging

Digital Fluoroscopic Camera

K070390

CDL Technologies Inc

Dental Material

K070537

Feel Tech (Korea)

Insulin Syringe

K070917

KHN Solutions

Breath Alcohol Detector

K071067

Vidar Systems Corp

Digital X-Ray System

K071193 (Special)

MBL International Corp (Japan)

IVD Elisa Kits

K071961

MI Tech Co. Ltd (Korea)

Esophageal Stent

K072094

Airistar

Medical Air Purifier

K072185

CRS Medical

Fibrin Analysis Catheter Test System

K072518

Dooyang Systems (Korea)

LCD Monitors

K072532

Takara Belmont (Japan)

Cone Beam CT

K072574

Almana Medical (Saudi Arabia)

Diagnostic X-Ray Systems

K072659

Ralco (Italy)

X-Ray Collimator, Automatic

K072780

Kavo (Germany)

Surgical Laser

K073074

IMIX ADR (Finland)

Digital X-Ray System

K073114

EBI, Inc. (Korea)

Endosseous Implant

K073116

AIIA Communication Inc. (Korea)

Body Composition Analyzer

K073227

Fujifilm Medical Systems

Digital X-Ray System

K073650

FIM Medical (France)

CO Tester

K080278

The Ashley Collection

Key Ring Alcohol Tester

K080286

Meinntech CO., LTD (Korea)

Intravascular Administration Set

K080303

Ralco s.r.l. (Italy)

X-Ray Collimator, Automatic

K080329

Medicatech USA

Digital X-Ray Systems

K080582

MAC Medical

Irrigation Solution Warmer

K080609

Almana Medical Imaging (Saudi Arabia)

Digital X-Ray System

K080614

Almana Medical Imaging (Saudi Arabia)

Fluoroscopy System

K080847

Q3 Innovations

Breath Alcohol Detector

K080848

Feel Tech (Korea)

Insulin Pen Needle

K080904

Elekta Neuromag OY (Finland)

EEG with Filter

K081430

Warantec Co. Ltd (Korea)

Dental Implant System

K081748

Amplivox (UK)

Auditory Impedance Tester

K081841

Almana Medical Imaging (Saudi Arabia)

Diagnostic X-Ray Systems

K082064

dxRAD (Canada)

Digital X-Ray Systems

K082261

Viztek

Digital X-Ray Systems

K082604

Minxray

Digital X-Ray Systems

K082627

Medicatech USA

Digital X-Ray Systems

K082798

Suinsa (Spain)

Diagnostic X-Ray Systems

K083109

Stingray Surgical Products

Electrosurgical Forceps

K083162

Virtual Imaging

Fluoroscopic C-Arm

K083725

KHN Solutions

Breath Alcohol Tester

K083801

Ljungberg-Kogel (Sweden)

Wireless Option for Bloodbank Scale/Mixer

BK090010

KHN Solutions

Breath Alcohol Tester

K090061

KHN Solutions

Breath Alcohol Tester

K090067

Sedecal (Spain)

Digital X-Ray Systems

K090238

Sedecal (Spain)

Digital X-Ray Systems

K090279

Sedecal (Spain)

Modified Mobile X-Ray (Film and Digital)

K090322

Minxray (Japan)

Dental X-Ray

K091255

Elekta Neuromag OY (Finland)

Source Localization Software

K091393

Silver Bay LLC

Light Therapy Device

K091467

Masters Healthcare

Insulin Syringes

K091474

Ralco s.r.l. (Italy)

X-Ray Collimator, Automatic

K091517

Viztek

Digital Stationary X-Ray

K091752

Eidosmed

Electronic Depth Gauge

K091992

Nidacon International AB (Sweden)

Reproductive Media

K092107

Virtual Imaging (Canon)

Radiographic Printer

K092280

GN Otometrics (Denmark)

Evoked Response System

K092373

Virtual Imaging (Canon)

Digital Fluoroscopic Panel

K092439

Biospace Corporation LTD (Korea)

Body Composition Analyzer

K092786

Synvasive Technology

Intraoperative Orthopedic Joint Assessment Aid

K093046

MEDSYNAPTIC PRIVATE, LTD (India)

PACS Software

K093247

Lumos, Inc

Collimator

K093596

Virtual Imaging (Canon)

Digital Fluoroscopic System

K093688

Almana Medical Imaging (Saudi Arabia)

Digital Mobile X-Ray

K100001

Xceram USA

Dental Material

K100250

Minxray (Japan)

Digital Mobile X-Ray

K100449

Brain Tunnelgenix Technologies

Electronic Clinical Thermometer

K100843

Imix ADR Finland OY (Finland)

Digital Stationary X-Ray

K101435

Viztek

Digital Stationary X-Ray

K102123

MHC Medical Products

Piston Syringe

K102178

Stephanix Radiological Systems (France)

Digital Fluoroscopic System

K102529

Sedecal (Spain)

Portable X-Ray

K103522

Panoramic Corp

Digital Panographic Dental X-Ray

K110371

510(k) Search

 Revised April 2011

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