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
73–96 of 195
Cleared Jan 29, 1998
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
K971670
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 268d
Cleared Aug 20, 1997
DM-400 HOLTER ECG CASSETTE RECORDER
K970298
Diagnostic Monitoring
Cardiovascular · 205d
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared May 05, 1997
MEDILOG FD4
K970902
Oxford Instruments Medical Systems
Cardiovascular · 55d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174
Del Mar Avionics
Cardiovascular · 211d
Cleared Mar 07, 1997
MODEL 700
K944180
Memtec Corp.
Cardiovascular · 924d
Cleared Jul 31, 1996
NORTHEAST MONITORING DR180
K960925
North East Monitoring, Inc.
Cardiovascular · 147d
Cleared Oct 12, 1995
VITALOGRAPH 2110 SOFTWARE INTERFACE
K950854
Vitalograph , Ltd.
Cardiovascular · 227d
Cleared Aug 17, 1995
HOLTER PACERCORDER(R)
K950020
Del Mar Avionics
Cardiovascular · 225d
Cleared Jul 14, 1995
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
K951605
Spacelabs, Inc.
Cardiovascular · 98d
Cleared Jun 07, 1995
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
K943862
Oxford Instruments Medical Systems
Cardiovascular · 303d
Cleared May 10, 1995
HOLTER SSR DIGICORDER(TM)
K942653
Del Mar Avionics
Cardiovascular · 341d
Cleared Apr 12, 1995
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
K945130
Braemar Corp.
Cardiovascular · 175d
Cleared Jan 24, 1995
DIGITAL HOLTER RECORDER
K942781
Agilent Technologies
Cardiovascular · 225d
Cleared Jan 18, 1995
HEARTPRINT
K942862
Medata, Inc.
Cardiovascular · 215d
Cleared Oct 20, 1994
TRACKER 2/TRACKER 3 HOLTER RECORDER
K943278
Reynolds Medical , Ltd.
Cardiovascular · 105d
Cleared Aug 05, 1994
ALTAIR 6100 CASSETTE RECORDER
K942438
Burdick, Inc.
Cardiovascular · 77d
Cleared Jan 13, 1994
SCOLE 300 ECG RECORDER
K923664
Scole Engineering Co.
Cardiovascular · 540d
Cleared Dec 03, 1993
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660
R & D Batteries, Inc.
Cardiovascular · 66d
Cleared Nov 01, 1993
MULTITRAK-PLUS
K930894
Zymed Medical Instrumentation
Cardiovascular · 252d
Cleared Sep 09, 1993
HRV 4000EM
K932929
All-Tronics Medical Systems
Radiology · 86d
Cleared Apr 06, 1992
UNISCAN 24 ECG ROCORDER
K920572
Uniscan , Ltd.
Cardiovascular · 59d
Cleared Mar 30, 1992
GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300
K921068
Datrix
Cardiovascular · 24d
Cleared Oct 16, 1991
CARD GUARD, MODELS CG-6000 & CG-7000
K910884
Card Guard Scientific Survival , Ltd.
Cardiovascular · 226d