DSI · Class II · 21 CFR 870.1025

FDA Product Code DSI: Detector And Alarm, Arrhythmia

Leading manufacturers include Siemens Medical Solutions USA, Inc., Fukuda Denshi USA, Inc. and Nihon Kohden America, Inc..

398
Total
398
Cleared
150d
Avg days
1976
Since
398 devices
169–192 of 398
Cleared Jul 20, 1993
CC ARHYTHMIS MONITORING OPTION
K923747
Hewlett-Packard Co.
Cardiovascular · 376d
Cleared Dec 18, 1992
BSM-8800A BEDSIDE MONITOR
K920154
Nihon Kohden America, Inc.
Cardiovascular · 340d
Cleared Sep 03, 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743
Nihon Kohden America, Inc.
Cardiovascular · 202d
Cleared May 28, 1992
BSM-2100A CONFIGURED PATIENT MONITOR
K914092
Nihon Kohden America, Inc.
Cardiovascular · 259d
Cleared Apr 29, 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
K913117
Nihon Kohden America, Inc.
Cardiovascular · 289d
Cleared Apr 27, 1992
ESCORT-LINK ARRHYTHMIA OPTION 23L
K915153
Medical Data Electronics
Cardiovascular · 165d
Cleared Mar 19, 1992
OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.
K910929
Ohmeda Medical
Cardiovascular · 380d
Cleared Jan 08, 1992
HORIZON PACEMAKER DETECTION SOFTWARE
K913339
Mennen Medical, Inc.
Cardiovascular · 166d
Cleared Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744
Nihon Kohden America, Inc.
Cardiovascular · 171d
Cleared Dec 04, 1991
TYPE 9210 S/ECG
K903940
S & W Medico Teknik
Cardiovascular · 464d
Cleared Oct 31, 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Sep 06, 1991
ACCUCORE TELEMETRY, MODIFICATION
K905506
S & W Medico Teknik
Cardiovascular · 281d
Cleared Jul 17, 1991
Q-SMART HOLTER SYSTEMS
K910808
Quinton, Inc.
Cardiovascular · 141d
Cleared Apr 26, 1991
ARRHYTHMIA 9215
K900366
S & W Medico Teknik
Cardiovascular · 455d
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Jan 30, 1991
FUKUDA DENSHI MODEL LX-3100
K903514
Fukuda Denshi USA, Inc.
Cardiovascular · 180d
Cleared Nov 05, 1990
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
K900720
Mortara Instrument, Inc.
Cardiovascular · 264d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704
Fukuda Denshi USA, Inc.
Cardiovascular · 87d
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246
Ppg Industries, Inc.
Cardiovascular · 167d
Cleared Apr 18, 1990
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
K896862
Del Mar Avionics
Cardiovascular · 133d
Cleared Apr 04, 1990
ELATEC HOLTER ANALYZER
K895806
Ela Medical, Inc.
Cardiovascular · 188d
Cleared Feb 08, 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543
Del Mar Avionics
Cardiovascular · 203d