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
73–96 of 398
Cleared Sep 11, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624
Siemens Medical Solutions USA, Inc.
Cardiovascular · 303d
Cleared Sep 09, 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585
Fukuda Denshi USA, Inc.
Cardiovascular · 207d
Cleared Aug 15, 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348
Siemens Medical Solutions USA, Inc.
Cardiovascular · 198d
Cleared Jul 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920
Siemens Medical Solutions USA, Inc.
Cardiovascular · 139d
Cleared Jun 04, 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062
Siemens Medical Solutions USA, Inc.
Cardiovascular · 168d
Cleared May 15, 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832
Hewlett-Packard Co.
Cardiovascular · 164d
Cleared May 01, 1997
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
K964187
Fukuda Denshi USA, Inc.
Cardiovascular · 192d
Cleared Apr 02, 1997
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
K952912
Spacelabs Medical, Inc.
Cardiovascular · 646d
Cleared Mar 25, 1997
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
K962970
Spacelabs Medical, Inc.
Cardiovascular · 237d
Cleared Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057
Fukuda Denshi USA, Inc.
Cardiovascular · 227d
Cleared Feb 24, 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827
Marquette Electronics, Inc.
Cardiovascular · 220d
Cleared Jan 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291
Siemens Medical Solutions USA, Inc.
Cardiovascular · 229d
Cleared Jan 17, 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404
Siemens Medical Solutions USA, Inc.
Cardiovascular · 210d
Cleared Jan 08, 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Oct 10, 1996
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
K961165
Hewlett-Packard Co.
Cardiovascular · 199d
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 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