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 Apr 04, 1996
CARDIO PERFECT ST 2001
K935732
Cardio Control BV
Cardiovascular · 855d
Cleared Nov 27, 1995
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
K945944
Nihon Kohden America, Inc.
Cardiovascular · 357d
Cleared Oct 06, 1995
ZYMED TELEMETRY SYSTEM
K951370
Zymed Medical Instrumentation
Cardiovascular · 193d
Cleared Oct 04, 1995
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
K951371
Siemens Medical Solutions USA, Inc.
Cardiovascular · 191d
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 28, 1995
3050 DIASCOPE NT PATIENT MONITOR
K942196
S & W Medico Teknik A/S
Cardiovascular · 420d
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 Jan 30, 1995
PACIFIC COMMUNICATIONS MODEL 1100
K942147
Accucore, Inc.
Cardiovascular · 272d
Cleared Dec 05, 1994
MODEL ACUITY CENTRAL STATION
K935846
Protocol Systems, Inc.
Cardiovascular · 362d
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 Feb 07, 1994
BATTERY PACK 1017LA
K931716
Portable Power Systems, Inc.
Cardiovascular · 307d
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 Feb 25, 1993
MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR
K925411
Accucore, Inc.
Cardiovascular · 122d
Cleared Feb 17, 1993
AMBULATORY (HOLTER) RECORDING, MODIFICATION
K922027
Biosensor Corp.
Cardiovascular · 328d