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
145–168 of 398
Cleared Oct 02, 1996
EAGLE PATIENT MONITOR
K960418
Marquette Electronics, Inc.
Cardiovascular · 247d
Cleared Aug 09, 1996
EAGLE PATIENT MONITOR MODEL 3000/3100
K961139
Marquette Electronics, Inc.
Cardiovascular · 141d
Cleared Jul 08, 1996
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743
Siemens Medical Solutions USA, Inc.
Cardiovascular · 203d
Cleared Jun 07, 1996
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
K952054
Siemens Medical Solutions USA, Inc.
Cardiovascular · 403d
Cleared Jun 07, 1996
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
K955059
Siemens Medical Solutions USA, Inc.
Cardiovascular · 214d
Cleared May 29, 1996
SOLAR 9000 ANESTHESIA INFORMATION MONITOR
K954852
Marquette Electronics, Inc.
Cardiovascular · 219d
Cleared May 22, 1996
QUEST EXERCISE STRESS SYSTEM
K952417
Burdick, Inc.
Cardiovascular · 365d
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 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 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 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