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
49–72 of 398
Cleared Aug 27, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
K091971
Corventis, Inc.
Cardiovascular · 57d
Cleared May 22, 2009
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
K090037
Medicalgorithmics SP Z.O.O.
Cardiovascular · 136d
Cleared May 15, 2009
EPICARDIA 5000
K090834
Medicomp, Inc.
Cardiovascular · 49d
Cleared Feb 03, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
K083287
Corventis, Inc.
Cardiovascular · 88d
Cleared Jan 16, 2009
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
K083517
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Cardiovascular · 51d
Cleared Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
K082475
Medtronic, Inc.
Cardiovascular · 71d
Cleared Oct 03, 2008
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
K082633
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Cardiovascular · 23d
Cleared Jul 31, 2008
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
K081444
Braemar, Inc.
Cardiovascular · 70d
Cleared May 29, 2008
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
K081257
Card Guard Scientific Survival , Ltd.
Cardiovascular · 27d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889
Ge Healthcare
Cardiovascular · 315d
Cleared Dec 18, 2007
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K071995
Card Guard Scientific Survival , Ltd.
Cardiovascular · 151d
Cleared Nov 21, 2007
REVEAL XT
K071641
Medtronic, Inc.
Cardiovascular · 159d
Cleared Nov 21, 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
K071655
Medtronic, Inc.
Cardiovascular · 156d
Cleared Nov 21, 2007
VITALOGIK MODEL 4000/4500
K073140
Mennen Medical , Ltd.
Cardiovascular · 14d
Cleared Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805
Datascope Corp.
Cardiovascular · 85d
Cleared Mar 16, 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976
Ge Medical Systems Information Technologies
Cardiovascular · 168d
Cleared Feb 23, 2007
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
K070260
Philips Medical Systems
Cardiovascular · 28d
Cleared Apr 25, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
K053263
Cardionet, Inc.
Cardiovascular · 154d
Cleared Dec 20, 2005
VITALOGIK
K052288
Mennen Medical , Ltd.
Cardiovascular · 119d
Cleared Dec 16, 2005
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
K052160
Welch Allyn, Inc.
Cardiovascular · 129d
Cleared Jun 14, 2005
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
K050919
Analogic Corp.
Cardiovascular · 63d
Cleared May 03, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050605
Spacelabs Medical, Inc.
Cardiovascular · 54d
Cleared Mar 04, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050175
Spacelabs Medical, Inc.
Cardiovascular · 37d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
K024213
Siemens Medical Solutions USA, Inc.
Cardiovascular · 459d