DSI · Class II · 21 CFR 870.1025

FDA Product Code DSI: Detector And Alarm, Arrhythmia

Leading manufacturers include Siemens Medical Solutions USA, Inc., Hewlett-Packard Co. and Medtronic, Inc..

398
Total
398
Cleared
150d
Avg days
1976
Since
398 devices
25–48 of 398
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376
Hewlett-Packard Co.
Cardiovascular · 263d
Cleared Nov 16, 1998
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
K983980
Siemens Medical Solutions USA, Inc.
Cardiovascular · 7d
Cleared Nov 06, 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Sep 09, 1998
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
K980429
Hewlett-Packard Co.
Cardiovascular · 217d
Cleared Aug 24, 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730
Siemens Medical Solutions USA, Inc.
Cardiovascular · 39d
Cleared Jul 08, 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698
Siemens Medical Solutions USA, Inc.
Cardiovascular · 204d
Cleared Jun 05, 1998
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared May 19, 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Sep 11, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624
Siemens Medical Solutions USA, Inc.
Cardiovascular · 303d
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 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 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 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 Jun 27, 1995
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306
Siemens Medical Solutions USA, Inc.
Cardiovascular · 181d