DSH · Class II · 21 CFR 870.2800

FDA Product Code DSH: Recorder, Magnetic Tape, Medical

Leading manufacturers include Del Mar Avionics, Bardy Diagnostics, Inc. and iRhythm Technologies, Inc..

195
Total
195
Cleared
125d
Avg days
1976
Since
195 devices
97–120 of 195
Cleared Oct 16, 1991
WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
K913600
Ralin Laboratories, Inc.
Cardiovascular · 64d
Cleared Oct 04, 1991
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
K913038
Spacelabs, Inc.
Cardiovascular · 87d
Cleared Sep 20, 1991
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
K904176
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Sep 20, 1991
GALIX MA-6C HOLTER CASSETTE RECORDER
K904177
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Aug 19, 1991
MR-5200 FULL DISCLOSURE SYSTEM
K911257
Mennen Medical, Inc.
Cardiovascular · 151d
Cleared Aug 07, 1991
PR4
K911097
Mortara Instrument, Inc.
Cardiovascular · 148d
Cleared Jul 26, 1991
MULTICHANNEL RECORDING SYSTEM
K912427
Bionique
Cardiovascular · 56d
Cleared Mar 12, 1991
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE
K902766
Advanced Ischemia Recorders, Inc.
Cardiovascular · 264d
Cleared Oct 22, 1990
ROZINN 151
K903331
Rozinn Electronics, Inc.
Cardiovascular · 89d
Cleared Aug 23, 1990
CARDIOVISTA
K902486
Cardionostics, Inc.
Cardiovascular · 80d
Cleared May 22, 1990
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251
Aequitron Medical, Inc.
Cardiovascular · 67d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793
Del Mar Avionics
Cardiovascular · 138d
Cleared Jan 19, 1990
MODIFIED DR-2C/PMC 100
K896153
General Devices
Cardiovascular · 87d
Cleared Jan 04, 1990
MODEL MC6500 ELECTROCARDIOGRAPH
K895961
Cambridge Medical Instruments, Inc.
Cardiovascular · 86d
Cleared Oct 30, 1989
E-RAM
K884126
Reynolds Medical , Ltd.
Cardiovascular · 395d
Cleared Sep 08, 1989
EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
K893836
Quinton Electrophysiology Corp.
Cardiovascular · 107d
Cleared Jul 27, 1989
IMEX RHYTHM TEK
K890114
Racom, Inc.
Cardiovascular · 197d
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227
Edentec Corp.
Cardiovascular · 77d
Cleared Jun 05, 1989
MT9000 CHART RECORDER
K892067
Astro-Med, Inc.
Cardiovascular · 67d
Cleared Mar 15, 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647
Oxford Medilog, Inc.
Cardiovascular · 33d
Cleared Jan 05, 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330
Del Mar Avionics
Cardiovascular · 83d
Cleared Dec 05, 1988
POLYCORD II
K880303
Technetics, Inc.
Cardiovascular · 315d
Cleared Nov 09, 1988
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009
Del Mar Avionics
Cardiovascular · 49d
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366
Brentwood Instruments, Inc.
Cardiovascular · 55d