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
241–264 of 398
Cleared May 11, 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148
Del Mar Avionics
Cardiovascular · 69d
Cleared Apr 20, 1989
MEDILOG 6000-FD REPORT GENERATOR
K890330
Oxford Medilog, Inc.
Cardiovascular · 87d
Cleared Apr 19, 1989
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204
Mennen Medical, Inc.
Cardiovascular · 121d
Cleared Apr 19, 1989
MEDILOG EDITOR
K890338
Oxford Medilog, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1989
HTS 220 CARDIAC MONITOR
K884524
Life Sensing Instrument Company, Inc.
Cardiovascular · 165d
Cleared Apr 05, 1989
SUPERMON ARRHYTHMIA MODULE 7270
K882206
Kontron Instruments, Inc.
Cardiovascular · 314d
Cleared Mar 16, 1989
506 NON-INVASIVE VITAL SIGNS MONITOR
K884216
Criticare Systems, Inc.
Cardiovascular · 161d
Cleared Mar 06, 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106
Siemens Medical Solutions USA, Inc.
Cardiovascular · 158d
Cleared Feb 06, 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887
Del Mar Avionics
Cardiovascular · 76d
Cleared Jan 17, 1989
E550 ELECTROCARDIOGRAPH
K883440
Burdick Corp.
Cardiovascular · 155d
Cleared Jan 17, 1989
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
K884539
Rmv Medical (Romavat, Inc.)
Cardiovascular · 81d
Cleared Dec 27, 1988
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
K880505
Ppg Industries, Inc.
Cardiovascular · 326d
Cleared Dec 15, 1988
CENTURY COLOR TRACE
K884152
Biomedical Systems, Inc.
Cardiovascular · 73d
Cleared Nov 01, 1988
Q4000 OPTION FOR Q4000
K882978
Quinton, Inc.
Cardiovascular · 109d
Cleared Oct 17, 1988
CARDIOMEGA-T
K883410
Grandcor Medical Systems
Cardiovascular · 67d
Cleared Sep 22, 1988
EPICARDIA PC/FC
K883103
Medicomp, Inc.
Cardiovascular · 62d
Cleared Sep 20, 1988
HOLTER SCANNER
K881488
Cardiodata Corp.
Cardiovascular · 165d
Cleared Aug 02, 1988
MODEL MICRO SI AMBULATORY ECG MONITOR
K881905
Advanced Medical Products, Inc.
Cardiovascular · 88d
Cleared Jul 12, 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273
Mennen Medical, Inc.
Cardiovascular · 109d
Cleared Jul 12, 1988
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K882513
Cardiac Resucitator Corp.
Cardiovascular · 40d
Cleared Mar 09, 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664
Mortara Instrument, Inc.
Cardiovascular · 20d
Cleared Mar 01, 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816
Kontron Instruments, Inc.
Cardiovascular · 364d
Cleared Feb 22, 1988
RHYTHMSCAN
K871572
Brentwood Instruments, Inc.
Cardiovascular · 306d
Cleared Jan 29, 1988
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
K873533
Medical Electronics Laboratories, Inc.
Cardiovascular · 150d