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
217–240 of 398
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246
Ppg Industries, Inc.
Cardiovascular · 167d
Cleared Jun 28, 1990
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
K900319
Siemens Medical Electronics
Cardiovascular · 156d
Cleared May 17, 1990
PCI MODEL 2041-B TELEMETRY MONITOR
K896775
Accucore, Inc.
Cardiovascular · 167d
Cleared May 17, 1990
MODEL 215M PATIENT SIMULATOR
K897074
Dynatech/Nevada, Inc.
Cardiovascular · 146d
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 Mar 19, 1990
HTS 820 CARDIAC MONITOR
K896967
Life Sensing Instrument Company, Inc.
Cardiovascular · 91d
Cleared Mar 13, 1990
GRANDCOR/CARDIOLINE ECT STRESS TESTING
K895547
Grandcor Medical Systems
Cardiovascular · 181d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 302
K896771
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
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 26, 1990
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
K895266
Biosensor Corp.
Cardiovascular · 156d
Cleared Jan 18, 1990
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR
K896103
Advanced Medical Products, Inc.
Cardiovascular · 87d
Cleared Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Dec 12, 1989
ZYMED MODEL 1610
K895208
Agilent Technologies
Cardiovascular · 117d
Cleared Oct 30, 1989
1100 VITAL SIGNS MONITOR
K884643
Criticare Systems, Inc.
Cardiovascular · 357d
Cleared Oct 12, 1989
CARE 5000 SYSTEM
K894858
Care Systems, Inc.
Cardiovascular · 73d
Cleared Oct 02, 1989
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
K894460
Siemens Medical Electronics
Cardiovascular · 76d
Cleared Oct 02, 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Sep 26, 1989
DMI PC HOLTER SCANNER
K894285
Diagnostic Medical Instruments
Cardiovascular · 95d
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 31, 1989
MEDILOG EXCEL ECG ANALYSIS SYSTEM
K885256
Oxford Medical, Inc.
Cardiovascular · 159d