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

Decided510(k)Device and applicantCode
Aug 23, 1990K901817FUKUDA DENSHI MODEL FX-3101
Fukuda Denshi USA, Inc.
DPS
Jul 17, 1990K901948CARDISUNY 501BIII
Graham-Field, Inc.
DPS
Jul 17, 1990K901947CARDISUNY 501AB
Graham-Field, Inc.
DPS
May 30, 1990K901771SIEMENS SIRECUST 732, PATIENT MONITOR
Siemens Medical Electronics
DPS
Apr 30, 1990K897121QEKG ELECTROCARDIOGRAPH
Qmed, Inc.
DPS
Apr 26, 1990K900598TRAMSCOPE SYSTEM
Marquette Electronics, Inc.
DPS
Apr 26, 1990K897029MODEL ECG100 SIMULATOR
Dynatech/Nevada, Inc.
DPS
Apr 4, 1990K901032PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
Accucore, Inc.
DPS
Apr 3, 1990K900700SMU 611 UNIVERSALMONITOR
Ppg Industries, Inc.
DPS
Mar 8, 1990K896190CARDIOCAP(TM) CMX-104 MONITOR
Datex Division Instrumentarium Corp., FI
DPS
Feb 26, 1990K896772EKG, ECG KENZ, ECG 303
Cambridge Medical Instruments, Inc.
DPS
Feb 5, 1990K894956CIRCAMED HOLTER VERSION 4
Circadian, Inc.
DPS
Jan 31, 1990K900272NKA MODELS AB-601G AND AB-621G
Nihon Kohden America, Inc.
DPS
Jan 26, 1990K896064AMBULATORY CARDIAC MONITOR
Monitech, Inc.
DPS
Dec 13, 1989K896386MINIMON 7133B PATIENT MONITOR
Kontron Instruments, Inc.
DPS
Dec 12, 1989K896417KONTRON KOLORMON 7250 PATIENT MONITOR
Kontron Instruments, Inc.
DPS
Dec 5, 1989K893660ECG SIMULATOR MODEL ECGPLUS
Bio-Tek Instruments, Inc.
DPS
Oct 17, 1989K890875CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
Ppg Industries, Inc.
DPS
Jun 22, 1989K884800ACTA GENOS ELECTROCARDIOGRAPH
Parexel Intl. Corp.
DPS
Jun 1, 1989K892835E350 ELECTROCARDIOGRAPH
Burdick Corp.
DPS
May 2, 1989K890791SIEMENS SIRECUST 730 PATIENT MONITOR
Siemens Medical Electronics
DPS
Apr 26, 1989K884116TYPE 9040 SYSTEM ATHENA
S & W Medico Teknik, DK
DPS
Mar 31, 1989K8904817610 COLORVIEW SLAVE SCOPE
Marquette Electronics, Inc.
DPS
Mar 31, 1989K885177PHYSIOGARD SM 785
Adam, FR
DPS
Mar 9, 1989K884504ELECTRODE GEL
Herbert Stanley Co.
DPS
Mar 9, 1989K883903NR2000 CARDIAC MONITOR
Nirad , Ltd., IE
DPS
Feb 23, 1989K884896BP-308 MARK II
Colin Medical Instruments Corp.
DPS
Feb 2, 1989K884662PATIENT MONITOR MODEL 703
Ivy Biomedical Systems, Inc.
DPS
Jan 25, 1989K883454MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH
Cambridge Medical Instruments, Inc.
DPS
Jan 17, 1989K883402EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
Quinton, Inc.
DPS
Jan 12, 1989K884992FUKUDA DENSHI MODEL FX-1201
Fukuda Denshi USA, Inc.
DPS
Dec 27, 1988K884956CARDIOCAP(TM) CTO-104 MONITOR
Datex Division Instrumentarium Corp., FI
DPS
Dec 27, 1988K883468Q5000 ST/HR SLOPE MODIFICATION
Quinton, Inc.
DPS
Dec 5, 1988K874326SYSTEM VI MONITOR
Air-Shields, Inc.
DPS
Nov 17, 1988K882472LOGIC 3 ELECTROCARDIOGRAPH
Cel-Med Co., Inc.
DPS
Nov 9, 1988K882254OEC-7102 ECG/NIBP MONITOR
Nihon Kohden America, Inc.
DPS
Aug 19, 1988K881055ECG MONITOR AND RESPIRATION PACER
D. E. Hokanson, Inc.
DPS
Aug 12, 1988K882197MINIMON 7131B PATIENT MONITOR
Kontron Instruments, Inc.
DPS
Aug 2, 1988K881475SYSTEM5RH STATIONARY EXERCISE BICYCLE
Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
DPS
Aug 2, 1988K880357OMNIGRAPH 6000
Telemed Div.
DPS
Jul 28, 1988K882198MINIMON 7132B PATIENT MONITOR
Kontron Instruments, Inc.
DPS
Jul 18, 1988K881939SIRECUST 1280/1281 & 960/961 PATIENT MONITORS
Siemens Medical Electronics
DPS
May 18, 1988K881328MODEL 375 ECG
Birtcher Corp.
DPS
May 6, 1988K880595HORIZON 2000/S 266-XXX-XXX
Mennen Medical, Inc.
DPS
Apr 1, 1988K874641CIRCADIAN STRESS TEST II
Circadian, Inc.
DPS
Mar 22, 1988K875057FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
Fukuda Denshi USA, Inc.
DPS
Jan 6, 1988K872658MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
Del Mar Avionics
DPS
Dec 15, 1987K872548FITNESS RECUMBENT ERGOMETER, MODEL FT1400
Invacare Corp.
DPS
Nov 23, 1987K871993MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH
Cambridge Medical Instruments, Inc.
DPS
Oct 26, 1987K873584MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
Quinton, Inc.
DPS

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