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
121–144 of 398
Cleared Feb 11, 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358
Mennen Medical, Inc.
Cardiovascular · 377d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Sep 25, 1997
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282
Spacelabs Medical, Inc.
Cardiovascular · 99d
Cleared Sep 12, 1997
TELE TRENS TM 10
K960884
Life Sensing Instrument Company, Inc.
Cardiovascular · 557d
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 30, 1997
DIASCOPE TRAVELLER PLUS (4053)
K964593
S & W Medico Teknik A/S
Cardiovascular · 227d
Cleared Jun 26, 1997
ESCORT LINK CENTRAL STATION MONITOR
K970012
Medical Data Electronics
Cardiovascular · 175d
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 08, 1997
DASH 1000 PATIENT MONITOR
K970545
Marquette Medical Systems, Inc.
Cardiovascular · 85d
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 22, 1997
BRENTWOOD PC-ECG
K955023
Brentwood Medical Products, Inc.
Cardiovascular · 447d
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