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
121–144 of 398
Cleared Jul 17, 1991
Q-SMART HOLTER SYSTEMS
K910808
Quinton, Inc.
Cardiovascular · 141d
Cleared Apr 26, 1991
ARRHYTHMIA 9215
K900366
S & W Medico Teknik
Cardiovascular · 455d
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Jan 30, 1991
FUKUDA DENSHI MODEL LX-3100
K903514
Fukuda Denshi USA, Inc.
Cardiovascular · 180d
Cleared Nov 05, 1990
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
K900720
Mortara Instrument, Inc.
Cardiovascular · 264d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704
Fukuda Denshi USA, Inc.
Cardiovascular · 87d
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Apr 18, 1990
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
K896862
Del Mar Avionics
Cardiovascular · 133d
Cleared Apr 04, 1990
ELATEC HOLTER ANALYZER
K895806
Ela Medical, Inc.
Cardiovascular · 188d
Cleared Feb 08, 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543
Del Mar Avionics
Cardiovascular · 203d
Cleared Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063
Fukuda Denshi USA, Inc.
Cardiovascular · 43d
Cleared Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Oct 02, 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Jun 22, 1989
SEER
K882818
Marquette Electronics, Inc.
Cardiovascular · 349d
Cleared Jun 16, 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323
Marquette Electronics, Inc.
Cardiovascular · 144d
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 05, 1989
SUPERMON ARRHYTHMIA MODULE 7270
K882206
Kontron Instruments, Inc.
Cardiovascular · 314d
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