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 15, 1996K955416CARDIMAX MODEL FX-2111
Fukuda Denshi USA, Inc.
DPS
Jul 11, 1996K955045OMNI-TRAK PATIENT MONITORING SYSTEM
Invivo Research, Inc.
DPS
Jul 2, 1996K955642NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
Nellcor Puritan Bennett, Inc.
DPS
May 30, 1996K960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
Biosensor Corp.
DPS
May 13, 1996K950989CARDIOSMART
Hellige GmbH, DE
DPS
Feb 29, 1996K950018CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
Cambridge Heart, Inc.
DPS
Oct 27, 1995K954066MINISCOPE MS-3
Schiller America, Inc.
DPS
Oct 24, 1995K950004HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
Aerotel, Ltd., IL
DPS
Oct 19, 1995K9534156200 VITAL SIGNS MONITOR
Bci Intl., Inc.
DPS
Aug 11, 1995K952173HEWLETT-PACKARD MODEL M1264B CATHSTATION
Hewlett-Packard Co.
DPS
Jun 28, 1995K945626QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
Quinton, Inc.
DPS
Jun 16, 1995K943709DINAMAP PLUS VITAL SIGNS MONOITOR
Critikon Company, LLC
DPS
Apr 25, 1995K950779HEART RATE VARIABILITY SOFTWARE OPTION
Spacelabs, Inc.
DPS
Mar 16, 1995K946205CARDIOVIT AT-1, P-80
Schiller America, Inc.
DPS
Dec 30, 1994K933156DATEX AS/3 PATIENT MONITOR
Datex Division Instrumentarium Corp., FI
DPS
Oct 20, 1994K935394MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
Marquette Electronics, Inc.
DPS
Aug 18, 1994K942629NCE REPLACEMENT BATTERIES
National Custom Ent., Inc.
DPS
May 17, 1994K941811HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
Hewlett-Packard Co.
DPS
Feb 17, 1994K934439RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR
Portable Power Systems, Inc.
DPS
Feb 17, 1994K933065BATTERY PACK# S1009LA
Portable Power Systems, Inc.
DPS
Feb 9, 1994K933404CRITIKON CENTRAL STATIN MONITOR
Critikon Company, LLC
DPS
Sep 22, 1993K923406BIOSCOPE
Biotronik, GmbH & Co.
DPS
Jul 29, 1993K924544CARDIAX
Fairlake Marketing Group, Inc.
DPS
May 7, 1993K921930SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI
Siemens Medical Electronics
DPS
Apr 27, 1993K930558MORTARA INSTRUMENT, INC. E-SCRIBE
Mortara Instrument, Inc.
DPS
Apr 27, 1993K922703THE ACTA FORMULA
Biosound, Inc.
DPS
Apr 9, 1993K9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
S & W Medico Teknik, DK
DPS
Mar 8, 1993K923221KING OF HEARTS SCEPTER
Instromedix, Inc.
DPS
Nov 10, 1992K922927MORTARA INSTRUMENT ST CENTRAL STATION
Mortara Instrument, Inc.
DPS
Nov 4, 1992K922291PERSONAL 120/210 LAPTOP STRESS OPTION
Biosound, Inc.
DPS
Jul 9, 1992K920020CARDIO-CARD ECG MANAGEMENT SYSTEM
Nasiff Assoc., Inc.
DPS
Jun 23, 1992K912183TYPE 9050/NEO
S & W Medico Teknik, DK
DPS
May 11, 1992K921331CAMBRIDGE PC/GXT STRESS TEST SYSTEM
Health Watch, Inc.
DPS
Mar 30, 1992K914206ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST
Kardiosis Ltd. Co.
DPS
Mar 17, 1992K920364ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
Biosound, Inc.
DPS
Feb 14, 1992K915760MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG
Corazonic Corp.
DPS
Jan 27, 1992K915879HL-300 RECEIVER MODULE
Fukuda Denshi USA, Inc.
DPS
Jan 23, 1992K913374CARDIO PERFECT, CARDIO PERFECT MD
Cardio Control BV, NL
DPS
Dec 19, 1991K914974MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
Medtronic Vascular
DPS
Dec 5, 1991K914762MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR
Micromed
DPS
Nov 5, 1991K914725COORDINATOR, CABLE INPUT
Cardiotronics, Inc.
DPS
Nov 5, 1991K910017Q4500 STREE TEST MONITOR
Quinton, Inc.
DPS
Aug 29, 1991K903774LP-PLUS
Fidelity Medical, Inc.
DPS
May 23, 1991K904355CARDIOCAP II TM CH-RESP MONITORS
Instrumentarium Corp., FI
DPS
Mar 1, 1991K904606MODEL 405
Ivy Biomedical Systems, Inc.
DPS
Mar 1, 1991K903524HORIZON 2000 ST ANALYSIS OPTION
Mennen Medical, Inc.
DPS
Jan 3, 1991K903671ATHANS EKG STANDARDIZER
Advanced Medical Concepts, Inc.
DPS
Dec 13, 1990K904758CARDIOFAX ECG-8830A
Nihon Kohden America, Inc.
DPS
Dec 5, 1990K903722MICROMED QRS CARD
Nasiff Assoc., Inc.
DPS
Sep 11, 1990K902368PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
Esaote Biomedica Spa
DPS

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