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
193–216 of 398
Cleared Dec 18, 1992
BSM-8800A BEDSIDE MONITOR
K920154
Nihon Kohden America, Inc.
Cardiovascular · 340d
Cleared Dec 15, 1992
ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)
K924672
Agilent Technologies
Cardiovascular · 90d
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 Feb 14, 1992
RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM
K911835
Gs Microsystems
Cardiovascular · 295d
Cleared Jan 28, 1992
DATASCOPE MODEL VISA CENTRAL MONITOR
K913576
Accucore, Inc.
Cardiovascular · 169d
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 23, 1991
CARDIOSWISS CM-8
K910109
Care Systems, Inc.
Cardiovascular · 256d
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 Jul 09, 1991
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
K900385
Parexel Intl. Corp.
Cardiovascular · 526d
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 Oct 16, 1990
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K900607
Cardiodata Corp.
Cardiovascular · 250d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704
Fukuda Denshi USA, Inc.
Cardiovascular · 87d