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
265–288 of 398
Cleared Jun 05, 1984
LEAP FROG
K834211
Philips Medical Systems (Cleveland), Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
K834597
Spacelabs, Inc.
Cardiovascular · 109d
Cleared Jan 10, 1984
AMBULATORY MONITORING DEVICE
K833162
Oxford Medilog, Inc.
Cardiovascular · 116d
Cleared Nov 07, 1983
ARRHYTHMIA III CARDULE #1919
K832693
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274
Nihon Kohden America, Inc.
Cardiovascular · 191d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200
K823586
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Mar 31, 1983
SIRECUST 400
K830029
Analogic Corp.
Cardiovascular · 86d
Cleared Mar 17, 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306
Spacelabs, Inc.
Cardiovascular · 45d
Cleared Feb 28, 1983
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013
Medicomp, Inc.
Cardiovascular · 56d
Cleared Oct 18, 1982
LS6 ARRYTHMIA DISCRIMINATOR
K822616
Life Science Instrumentation, Inc.
Cardiovascular · 49d
Cleared Oct 04, 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718
Marquette Electronics, Inc.
Cardiovascular · 27d
Cleared Sep 28, 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030
Marquette Electronics, Inc.
Cardiovascular · 78d
Cleared May 18, 1982
MEMOPORT C
K820881
Litton Medical Electronics
Cardiovascular · 49d
Cleared Apr 29, 1982
QUINTON Q2000 ETT MONITORING SYSTEM
K820438
Quinton, Inc.
Cardiovascular · 71d
Cleared Apr 15, 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Dec 29, 1981
MICRO-PREPROCESSOR UNIT
K812914
General Electric Co.
Cardiovascular · 71d
Cleared Aug 13, 1981
ARRHYTHMIA FUNCTION BLOCK
K811581
Honeywell, Inc.
Cardiovascular · 69d
Cleared Jul 16, 1981
THE BETA
K810940
Burdick Corp.
Cardiovascular · 100d
Cleared Jul 10, 1981
ARRYTHMIA PRINTER OPTION
K811792
American Edwards Laboratories
Cardiovascular · 16d
Cleared Jun 12, 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122
Del Mar Avionics
Cardiovascular · 49d
Cleared May 27, 1981
SIRECUST 358
K803208
Siemens Corp.
Cardiovascular · 160d
Cleared Feb 27, 1981
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 60d
Cleared Sep 26, 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033
Oxford Medilog, Inc.
Cardiovascular · 35d