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
97–120 of 398
Cleared Oct 03, 1995
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821
Hewlett-Packard Co.
Cardiovascular · 222d
Cleared Sep 26, 1995
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
K952885
Spacelabs Medical, Inc.
Cardiovascular · 95d
Cleared Aug 15, 1995
SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)
K945429
Spacelabs Medical, Inc.
Cardiovascular · 281d
Cleared Jun 27, 1995
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306
Siemens Medical Solutions USA, Inc.
Cardiovascular · 181d
Cleared May 24, 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
K935877
Nihon Kohden America, Inc.
Cardiovascular · 531d
Cleared May 24, 1995
BSM-8800A BEDSIDE MONITOR
K944422
Nihon Kohden America, Inc.
Cardiovascular · 281d
Cleared May 17, 1995
SPACELABS MEDICAL ECG MODULE (MODEL 90492)
K942058
Spacelabs Medical, Inc.
Cardiovascular · 383d
Cleared May 10, 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384
Siemens Medical Solutions USA, Inc.
Cardiovascular · 188d
Cleared Apr 10, 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177
Siemens Medical Solutions USA, Inc.
Cardiovascular · 649d
Cleared Apr 10, 1995
SC 6000/ SC 6000P/ R50
K944350
Siemens Medical Solutions USA, Inc.
Cardiovascular · 216d
Cleared Oct 27, 1994
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
K925510
Spacelabs Medical, Inc.
Cardiovascular · 727d
Cleared Apr 19, 1994
MARQUETTE EAGLE MONITOR
K920790
Marquette Electronics, Inc.
Cardiovascular · 788d
Cleared Sep 03, 1993
SPACELABS MEDICAL PATIENT MONITOR
K930095
Spacelabs Medical, Inc.
Cardiovascular · 238d
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 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