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
May 23, 2001K011177BCI ADVISOR VITAL SIGNS MONITOR (9200)
Bci, Inc.
DPS
Apr 26, 2001K010955BMT ANSCORE HEALTH MANAGEMENT SYSTEM
Boston Medical Technologies, Inc.
DPS
Apr 18, 2001K010822AB CARDIETTE START 200 HV
H&C Medical Devices Spa, IT
DPS
Apr 12, 2001K010758HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
Cambridge Heart, Inc.
DPS
Mar 9, 2001K010505TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
Brentwood Medical Technology Corp.
DPS
Jan 31, 2001K002822VERTEX SYSTEM
Medical Positioning, Inc.
DPS
Jan 25, 2001K003392CARDIO MONITOR CENTER VISION; MODEL S-CV7-00
Shl Telemedicine International , Ltd., IL
DPS
Jan 8, 2001K001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
Suzuken Co., Ltd.
DPS
Dec 27, 2000K002197CARTOUCH
Cardionics, Inc.
DPS
Nov 8, 2000K002473WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
Nihon Kohden America, Inc.
DPS
Nov 8, 2000K002459PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
Agilent Technologies, Inc.
DPS
Oct 4, 2000K002074AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
H&C Medical Devices Spa, IT
DPS
Aug 11, 2000K993875BMT ANSCORE HEALTH MANAGEMENT SYSTEM
Boston Medical Technologies, Inc.
DPS
Aug 9, 2000K001492QUINTON Q-STRESS, MODEL 000483
Quinton, Inc.
DPS
Jun 9, 2000K001034MODEL APS ALTERNANS PROCESSING SYSTEM
Cambridge Heart, Inc.
DPS
May 24, 2000K000645GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
General Electric Medical Systems Information Techn
DPS
Apr 7, 2000K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
Prucka Engineering, Inc.
DPS
Nov 18, 1999K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
General Electric Medical Systems Information Techn
DPS
Jun 11, 1999K991831BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
Boston Medical Technologies, Inc.
DPS
Dec 3, 1998K972991MONITOR ONE NDX
Qmed, Inc.
DPS
Oct 14, 1998K981697CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
Cambridge Heart, Inc.
DPS
Aug 25, 1998K974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
Micromedical, Inc.
DPS
Aug 19, 1998K981807CARDIOVISION SOFTWARE, MODEL S-CV5-96
Shl Telemedicine International , Ltd., IL
DPS
Aug 12, 1998K973426ANS 2000 ECG MONITOR AND RESPIRATION PACER
D. E. Hokanson, Inc.
DPS
Aug 5, 1998K961798CT 200 ELECTROCARDIOGRAPH
Macquarie Medical Systems
DPS
Jul 28, 1998K981951CT 100 ELECTROCARDIOGRAPH
Macquarie Medical Systems
DPS
Jun 30, 1998K980362MRI COMPATIBLE MONITOR AND ACCESSORIES
Datex-Engstrom, Inc.
DPS
Apr 28, 1998K972996EASY ECG PC BASED ELECTROCARDIOGRAPH
Ates Medical S.R.L.
DPS
Apr 1, 1998K974351BIOLOG 3000 ELECTROCARDIOGRAPH
Micromedical, Inc.
DPS
Mar 18, 1998K974746M1765A ECG MANAGER
Hewlett-Packard Co.
DPS
Mar 11, 1998K972603ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
Dr. Lee Co., Ltd.
DPS
Jan 22, 1998K974079FORMULA FOR ARCHIMED
Biosound Esaote, Inc.
DPS
Dec 3, 1997K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
Hewlett-Packard GmbH, DE
DPS
Oct 21, 1997K972746ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
Alexander Mfg. Co.
DPS
Sep 25, 1997K972199SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
Marquette Electronics, Inc.
DPS
Sep 24, 1997K971038KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE
Kontron Instruments , Ltd., GB
DPS
Aug 20, 1997K972310NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
Nihon Kohden America, Inc.
DPS
Aug 13, 1997K964784SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
Quinton, Inc.
DPS
Jul 23, 1997K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
Instromedix, Inc.
DPS
Jun 30, 1997K963578PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)
Intl. Products, Inc.
DPS
May 14, 1997K970787ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
Alexander Mfg. Co.
DPS
Mar 5, 1997K963198PS-41 6M PATIENT SIMULATOR
Metron U.S., Inc.
DPS
Nov 26, 1996K963400NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
Nellcor Puritan Bennett, Inc.
DPS
Oct 23, 1996K961247AS/3 LIGHT MONITOR
Datex Division Instrumentarium Corp.
DPS
Oct 8, 1996K961401HP CATHSTATION - MODEL M1264B
Hewlett-Packard Co.
DPS
Oct 8, 1996K955891CARDIOVIEW TRANSTELEPHONIC SOFTWARE
Micromedical, Inc.
DPS
Aug 28, 1996K951128MEDILOG STRESSLINK
Oxford Medical, Inc.
DPS
Aug 21, 1996K960321CARDIOCATH CATHETERIZATION LAB SYSTEM
Prucka Engineering, Inc.
DPS
Aug 16, 1996K955546PATIENT MONITOR MODEL 405P
Ivy Biomedical Systems, Inc.
DPS
Aug 15, 1996K955113DINAMAP SELECT MULTI-PARAMETER SYSTEM
Johnson & Johnson Medical, Inc.
DPS

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