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
361–384 of 398
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 29, 1982
EVENTMASTER 2
K820856
Instruments For Cardiac Research
Cardiovascular · 31d
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 Dec 14, 1981
CC-201 ECG MONITORING SYSTEMS
K813287
Anthro-Metrics Corp.
Cardiovascular · 21d
Cleared Aug 31, 1981
CARDIO-DATA SYSTEM, #MARK III
K812149
Cardio Data
Cardiovascular · 34d
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 16, 1981
CC-103
K811527
Anthro-Metrics Corp.
Cardiovascular · 15d
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 Mar 26, 1981
DATAMEDIX PECGASYS SYSTEM
K810027
Datamedix
Cardiovascular · 80d
Cleared Mar 11, 1981
SERIES 4000 STRESS & EXERCISE SYSTEM
K801903
Instruments For Cardiac Research
Cardiovascular · 212d
Cleared Mar 11, 1981
HEART SENTINEL
K802900
Totemite Medical Electronics
Cardiovascular · 114d
Cleared Feb 27, 1981
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 60d
Cleared Jan 07, 1981
CC101 ECG MONITORING SYSTEM
K802312
Anthro-Metrics Corp.
Cardiovascular · 106d
Cleared Nov 26, 1980
BIOMETRIC ERG SYSTEM
K802472
Biometric Analysis Group, Inc.
Cardiovascular · 48d
Cleared Sep 26, 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033
Oxford Medilog, Inc.
Cardiovascular · 35d
Cleared Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103
General Electric Co.
Cardiovascular · 23d
Cleared Sep 26, 1980
COMPUTER ECG TERMINAL
K802272
Compumed, Inc.
Cardiovascular · 9d
Cleared Sep 09, 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831
Del Mar Avionics
Cardiovascular · 39d
Cleared Aug 27, 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762
General Electric Co.
Cardiovascular · 30d