ClearanceBrief
Panels › Cardiovascular › Product code DPS · Class 2

Electrocardiograph

Regulation 870.2340

8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in DPS

Company510(k)sRecalls
Smiths Medical PM, Inc.038
Mortara Instrument, Inc.211
Nihon Kohden America, Inc.210
Edan Instruments, Inc.191
Quinton, Inc.170
WELCH ALLYN, INC/MORTARA016
Hewlett-Packard Co.150
Philips North America014
Burdick Corp.120
Philips Medical Systems92
Decided510(k)Device and applicantCode
Dec 28, 2018K183369COR12 ECG
Corscience GmbH & Co., DE
DPS
Dec 14, 2018K182790Cardio-TriTest v6.5
Cardio-Phoenix, Inc., CA
DPS
Nov 15, 2018K181998CardioBand ECG Event Recorder
Samsung Strategy and Innovation Center (Ssic)
DPS
Sep 18, 2018K173830MAC VU360 Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
DPS
Aug 28, 2018K173952Universal SmartECG
Vectracor, Inc.
DPS
Aug 10, 2018K180234physiQ Heart Rhythm Module
Physiq, Inc.
DPS
Jul 5, 2018K172778CheckMyHeart Plus
Dailycare Biomedical, Inc., TW
DPS
Jun 1, 2018K172068Kenz Cardico1211
Suzuken Co., Ltd., JP
DPS
Apr 16, 2018K173226CardiMax Electrocardiograph
Fukuda Denshi USA, Inc.
DPS
Feb 28, 2018K180242HeRO Symphony, HeRO ES, HeRO solo/duet
Medical Predictive Science Corporation
DPS
Jan 26, 2018K162665MiCor A100 Wearable ECG Recorder
Mitac International Corp., TW
DPS
Jan 24, 2018K171942Electrocardiograph
Edan Instruments, Inc., CN
DPS
Jan 22, 2018K171360CONTEC™ Electrocardiograph
Contec Medical Systems Co.,Ltd, CN
DPS
Jan 11, 2018K171517Digital Electrocardiograph
Biocare Bio-Medical Equipment Co., Ltd., CN
DPS
Dec 15, 2017K163607ECG Acquisition Systems
Vales & Hills Biomedical Tech. , Ltd., CN
DPS
Oct 12, 2017K170154Creavo Vitalscan Magnetocardiograph
Creavo Medical Technologies, Ltd., GB
DPS
Sep 25, 2017K171943Electrocardiograph
Edan Instruments, Inc., CN
DPS
Jul 19, 2017K170182CARDIOVIT FT-1
Schiller AG, CH
DPS
Jun 26, 2017K170568CardioLogs ECG Analysis Platform
Cardiologs Technologies, FR
DPS
Jun 2, 2017K170995Electrocardiograph
Edan Instruments, Inc., CN
DPS
May 30, 2017K170954Portable ECG Monitor
Contec Medical Systems Co.,Ltd, CN
DPS
May 11, 2017K160667Anybattery C2 Rechargeable Battery
Anybattery, Inc.
DPS
Feb 15, 2017K160876PC ECG
Edan Instruments, Inc., CN
DPS
Nov 2, 2016K160746CARDIOLINE touchECG
Cardioline S.P.A, IT
DPS
Aug 12, 2016K160840ECG100+, ECG200+
Cardioline S.P.A, IT
DPS
Aug 9, 2016K152135Quantitative Electrocardiographic Detector (QED 2000)
Acme Portable Machines, Inc.
DPS
Jul 1, 2016K161302PC ECG
Edan Instruments, Inc., CN
DPS
Jun 22, 2016K152863Portable ECG Monitor
Contec Medical Systems Co.,Ltd, CN
DPS
May 6, 2016K152043Diagnostic Station DS20
Schiller AG, CH
DPS
Mar 15, 2016K151135MODEL 621/624 BIOMAGNETOMETER
Tristan Technologies, Inc.
DPS
Feb 23, 2016K142969ANI Monitor
Mdoloris Medical Systems Sas, FR
DPS
Feb 12, 2016K160092Digital Electrocardiograph
Shenzhen Biocare Bio-Medical Equipment Co., Ltd., CN
DPS
Feb 5, 2016K152427PC ECG
Edan Instruments, Inc., CN
DPS
Jan 6, 2016K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
Mortara Instrument, Inc.
DPS
Dec 18, 2015K152384Digital Electrocardiograph
Shenzhen Biocare Bio-Medical Equipment Co., Ltd., CN
DPS
Aug 12, 2015K150564Spaulding Electrocardiograph 2100iQ
Spaulding Clinical Research, LLC
DPS
Jun 3, 2015K143432Cardio-TriTest
Cardio-Phoenix, Inc., CA
DPS
May 21, 2015K143436InvisionECG System
Invisionheart, Inc.
DPS
Apr 16, 2015K142551QANS (Quantitative Autonomic Nervous System) Monitoring System
Hhssystems, LLC
DPS
Feb 20, 2015K142693ZywieAI Software Library
Zywie, Inc.
DPS
Feb 13, 2015K141946DIGITAL ELECTROCARDIOGRAPH
Shenzhen Biocare Bio-Medical Equipment Co., Ltd., CN
DPS
Jan 22, 2015K133985DIGITAL ELECTROCARDIOGRAPH
Shenzhen Biocare Bio-Medical Equipment Co., Ltd., CN
DPS
Dec 3, 2014K142288MAC 800 Resting ECG Analysis System
Ge Medical Systems China Co., Ltd., CN
DPS
Oct 28, 2014K140020HYPERQ ACS-100 SYSTEM
Bsp-Biiological Signal Processing, Ltd., IL
DPS
Sep 5, 2014K142105ELI 380 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Jul 11, 2014K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
Welch Allyn
DPS
Jun 11, 2014K131858DIGITAL ELECTROCARDIOGRAPH
Guangdong Biolight Meditech Co., Ltd., CN
DPS
Mar 5, 2014K131900CONTEC ELECTROCARDIOGRAPH
Contec Medical System Co., Ltd., CN
DPS
Feb 25, 2014K131503SE-601 SERIES ELECTROCARDIOGRAPH
Edan Instruments, Inc., CN
DPS
Feb 11, 2014K122632GUAVA II
Cardiocomm Solutions, Inc.
DPS

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