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
385–398 of 398
Cleared Nov 13, 1979
COMPU-SCAN
K791632
Hittman Medical Systems
Cardiovascular · 84d
Cleared Nov 13, 1979
SPECTRA CENTRAL PT MONITORING SYS
K792081
American Optical Corp.
Cardiovascular · 28d
Cleared Aug 28, 1979
DCG-VII ELECTROCARDIOSCANNER
K791424
Del Mar Avionics
Cardiovascular · 28d
Cleared Aug 28, 1979
MODEL 78520A ARRHYTHMIA MONITORING SYS
K791487
Hewlett-Packard Co.
Cardiovascular · 22d
Cleared May 16, 1979
ARRHYTHMIA II CARDULE
K790837
Spacelabs, Inc.
Cardiovascular · 16d
Cleared Feb 28, 1979
ANALYZER, MEDILOG II
K790287
Oxford Medilog, Inc.
Cardiovascular · 20d
Cleared Nov 30, 1978
ECG ANALYZER, HIGH SPEED
K781911
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 16d
Cleared Nov 20, 1978
CAMSCAN SYSTEM
K781845
American Optical Corp.
Cardiovascular · 19d
Cleared May 26, 1978
ARRHYTHMIA PROGRAM MODULE
K780432
Midwest Analog & Digital, Inc.
Cardiovascular · 70d
Cleared Apr 18, 1978
ARRHYTHMIA TREND ENHANCEMENT
K780343
American Optical Corp.
Cardiovascular · 47d
Cleared Jan 12, 1978
ARRHYTHMIA MODULE
K772360
General Electric Co.
Cardiovascular · 16d
Cleared Aug 04, 1977
SCANNER TREND SYSTEM
K771374
Instruments For Cardiac Research
Cardiovascular · 10d
Cleared Feb 28, 1977
MONITORING & STRESS TESTING EQUIPMENT
K760368
Advanced Medical, Inc.
Cardiovascular · 208d
Cleared Dec 09, 1976
MICRO-COMPUTER ARRHYTHONIA SYSTEM
K760884
Spacelabs, Inc.
Cardiovascular · 48d