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 Oct 31, 2003
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K033305
Draeger Medical Systems, Inc.
Cardiovascular · 17d
Cleared Oct 10, 2003
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
K032858
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
K031433
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370
Ge Medical Systems Information Technologies
Cardiovascular · 12d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550
Datascope Corp.
Cardiovascular · 190d
Cleared Aug 21, 2002
COSMOS SYSTEM
K013046
Spacelabs Medical, Inc.
Cardiovascular · 345d
Cleared Aug 21, 2002
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
K022453
Welch Allyn Protocol, Inc.
Cardiovascular · 26d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097
Spacelabs Medical, Inc.
Cardiovascular · 85d
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300
Philips Medical Systems
Cardiovascular · 14d
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251
Philips Medical Systems
Cardiovascular · 18d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467
General Electric Medical Systems Information Techn
Cardiovascular · 194d
Cleared Feb 07, 2002
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K002604
Invivo Research, Inc.
Cardiovascular · 534d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Feb 01, 2002
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K012241
Cardionet, Inc.
Cardiovascular · 199d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336
Medical Data Electronics
Cardiovascular · 71d
Cleared Aug 20, 2001
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
K011339
Spacelabs Burdick, Inc.
Cardiovascular · 110d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461
Siemens Medical Solutions USA, Inc.
Cardiovascular · 16d
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784
Mennen Medical , Ltd.
Cardiovascular · 69d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120
Mennen Medical , Ltd.
Cardiovascular · 396d
Cleared Feb 22, 2001
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
K002758
Agilent Technologies Deutschland GmbH
Cardiovascular · 170d