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
Jul 2, 2010K101403ELI 250 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Jun 18, 2010K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
Mortara Instrument, Inc.
DPS
Jun 3, 2010K093211CARECENTER MD
Cardiac Science Corporation
DPS
Apr 16, 2010K100127ELI 230 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Apr 1, 2010K093869SE-601 SERIES ELECTROCARDIOGRAPH
Edan Instruments, Inc.
DPS
Mar 31, 2010K093872HANDHELD ECG MONITOR, MODEL MD100
Beijing Choice Electronic Technololgy Co., Ltd., CN
DPS
Feb 19, 2010K093339ELI PC ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Jan 20, 2010K093172QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
Dynacardia, Inc.
DPS
Dec 14, 2009K092663ELI 350 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Oct 22, 2009K092010PC ECG, MODEL SE-1010
Edan Instruments, Inc.
DPS
Sep 15, 2009K083715BELTBEAT WF-400
Bonus Communicaciones Srl, IL
DPS
Sep 4, 2009K092576GEM HEART ONE/ONE+
Gem-Med S.L., ES
DPS
Aug 25, 2009K090936SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
Contec Medical System Co., Ltd., CN
DPS
Jul 24, 2009K091513SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
Edan Instruments, Inc.
DPS
Jul 8, 2009K091397ECSCOPE 200
Dyansys, Inc.
DPS
Jun 3, 2009K090367SE-601 SERIES ELECTROCARDIOGRAPH
Edan Instruments, Inc.
DPS
May 28, 2009K091358ECSCOPE 100
Dyansys, Inc.
DPS
Apr 3, 2009K090249MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
Harbinger Medical, Inc.
DPS
Mar 26, 2009K082967MORTARA STRESS ECHO BED
Medical Positioning, Inc.
DPS
Mar 20, 2009K090483SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
Philips Medical Systems
DPS
Feb 19, 2009K090212MAC 800 RESTING ECG ANALYSIS SYSTEM
Ge Medical Syst. Information Technologies
DPS
Feb 19, 2009K082124CARDITTE MICROTEL
Et Medical Devices Spa, IT
DPS
Dec 29, 2008K082946MORTARA ELI 350 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Dec 29, 2008K082709VICOR PD2I ANALYZER, VERSION 2.1
Vicor Technologies, Inc.
DPS
Dec 3, 2008K082380VICARDIO 12B
Energy-Lab Technologies GmbH
DPS
Nov 10, 2008K082013CLUE MEDICAL AND CLUE MEDICAL BASIC
Telovital GmbH Telemedizin
DPS
Sep 26, 2008K080933HANDHELD ECG MONITOR, MODEL MD100
Beijing Choice Electronic Technololgy Co., Ltd., CN
DPS
Sep 12, 2008K082312PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
Heartscape Technologies, Ltd., GB
DPS
Aug 26, 2008K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
Cardiac Science Corporation
DPS
Jul 15, 2008K081437MAC 1600 ECG ANALYSIS SYSTEM
Ge Medical Systems Information Technologies
DPS
Jun 27, 2008K081473HERO, VERSION 2.0
Medical Predictive Science Corp.
DPS
May 9, 2008K080999PAGEWRITER CARDIOGRAPH
Philips Medical Systems
DPS
Apr 11, 2008K080884QHRV 1 - HEALTH ASSESSMENT SYSTEM
Medtechs, LLC
DPS
Jan 25, 2008K073625MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
Ge Healthcare Systems Information Technologies
DPS
Jan 16, 2008K080036PORTABLE ECSCOPE 12I
Dyansys, Inc.
DPS
Nov 29, 2007K072449CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
Welch Allyn, Inc.
DPS
Aug 31, 2007K071168THE PORTABLE ANSISCOPE
Dyansys, Inc.
DPS
Aug 30, 2007K072353PORTABLE ECSCOPE
Dyansys Corp
DPS
Aug 30, 2007K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
Nihon Kohden America, Inc.
DPS
Aug 17, 2007K072060QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
Nihon Kohden America, Inc.
DPS
Jun 29, 2007K061123PALM ECG RECORDER, MODEL EP-201/202
Parama-Tech Company., Ltd.
DPS
May 4, 2007K070614CORSCREEN
Viasys Healthcare GmbH, DE
DPS
Apr 13, 2007K070136AUDICOR 200 SYSTEM, MODELS 200D AND 200S
Inovise Medical, Inc.
DPS
Mar 22, 2007K062282MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
Monebo Technologies, Inc.
DPS
Mar 15, 2007K070539MORTARA ELI 10 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Feb 8, 2007K062894INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
Dailycare Biomedical, Inc., TW
DPS
Nov 15, 2006K062677ELI 350 ELECTROCARDIOGRAPH
Mortara Instrument, Inc.
DPS
Nov 3, 2006K062469VOYAGER 12
Del Mar Reynolds Medical, Ltd.
DPS
Oct 27, 2006K062068INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
Intelwave, LLC
DPS
Jun 9, 2006K060766PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
Omron Healthcare, Inc.
DPS

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