Recorder, Magnetic Tape, Medical

FDA product code DSH · 192 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2800
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-30 – 2026-07-09

DSH 1991-03-12

ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE

Applicant Advanced Ischemia Recorders, Inc.

K number K902766

View details →

DSH 1990-10-22

ROZINN 151

Applicant Rozinn Electronics, Inc.

K number K903331

View details →

DSH 1990-08-23

CARDIOVISTA

Applicant Cardionostics, Inc.

K number K902486

View details →

DSH 1990-05-22

MODEL 9101 RECORDER/ANALYZER SYSTEM

Applicant Aequitron Medical, Inc.

K number K901251

View details →

DSH 1990-02-13

MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION

Applicant Del Mar Avionics

K number K895793

View details →

DSH 1990-01-19

MODIFIED DR-2C/PMC 100

Applicant General Devices

K number K896153

View details →

DSH 1990-01-04

MODEL MC6500 ELECTROCARDIOGRAPH

Applicant Cambridge Medical Instruments, Inc.

K number K895961

View details →

DSH 1989-10-30

E-RAM

Applicant Reynolds Medical , Ltd.

K number K884126

View details →

DSH 1989-09-08

EPLAB (ELECTROCARDIOGRAPHIC MONITOR)

Applicant Quinton Electrophysiology Corp.

K number K893836

View details →

DSH 1989-07-27

IMEX RHYTHM TEK

Applicant Racom, Inc.

K number K890114

View details →

DSH 1989-06-20

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)

Applicant Edentec Corp.

K number K892227

View details →

DSH 1989-06-05

MT9000 CHART RECORDER

Applicant Astro-Med, Inc.

K number K892067

View details →

DSH 1989-03-15

MEDILOG 9000-II AMBULATORY RECORDER

Applicant Oxford Medilog, Inc.

K number K890647

View details →

DSH 1989-01-05

MODEL 463 ELECTROCARDIORECORDER RECORDER

Applicant Del Mar Avionics

K number K884330

View details →

DSH 1988-12-05

POLYCORD II

Applicant Technetics, Inc.

K number K880303

View details →

DSH 1988-11-09

MODEL 459 ELECTROCARDIOCORDER RECORDER

Applicant Del Mar Avionics

K number K884009

View details →

DSH 1988-08-02

RHYTHMSCAN HR HOLTER RECORDER

Applicant Brentwood Instruments, Inc.

K number K882366

View details →

DSH 1988-02-22

MODEL 492 SSR (TM) RECORDER

Applicant Del Mar Avionics

K number K874313

View details →

DSH 1988-01-29

PATIENTWATCH (TM)

Applicant Advanced Medical Technology, Inc.

K number K874571

View details →

DSH 1987-10-09

MODEL SSR1 HOLTER MONITOR

Applicant Cardiodata Corp.

K number K873337

View details →

DSH 1987-09-25

MODEL MICRO FD+ AMBULATORY ECG MONITOR

Applicant Advanced Medical Products, Inc.

K number K872508

View details →

DSH 1987-08-12

THE TELESCAN C.A.R.E. SYSTEM

Applicant Telescan Medical Systems

K number K871587

View details →

DSH 1987-08-11

TRANSCOR RADIO-STETHOSCOPE MB

Applicant Transcor, Inc.

K number K872234

View details →

DSH 1987-07-29

VITEL III, ECG TRANSMITTER

Applicant Equimed Corp.

K number K872229

View details →

DSH 1987-07-21

MODIFIED MODEL 9431 TELETRACE TRANSMITTER

Applicant Medtronic Vascular

K number K872246

View details →

DSH 1987-06-29

NIGHTWATCH(TM) SYSTEM

Applicant Buckman Co., Inc.

K number K870578

View details →

DSH 1987-06-24

FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)

Applicant Futurecare Systems, Inc.

K number K871944

View details →

DSH 1987-06-19

UMSC HOLTER MONITORING KIT

Applicant United Medical Supply Co., Inc.

K number K872087

View details →

DSH 1987-05-19

DMI AMBULATORY HOLTER MONITOR

Applicant Diagnostic Medical Instruments

K number K871045

View details →

DSH 1987-04-23

MODEL MICRO ST AMBULATORY ECG MONITOR

Applicant Advanced Medical Products, Inc.

K number K870537

View details →

DSH 1987-03-23

CASSETTE TAPE REPLAY SYSTEM

Applicant Research Instrumentation Associates, Inc.

K number K870554

View details →

DSH 1986-10-20

VERSAFLEX(TM) DELTA ST(TM) MONITOR

Applicant Versaflex Delivery Systems, Inc.

K number K863922

View details →

DSH 1986-10-15

CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)

Applicant Cardionostics, Inc.

K number K863863

View details →

DSH 1986-08-25

MINI-HOLTER, MODEL 2000

Applicant Holter Recorders

K number K862526

View details →

DSH 1986-08-18

SPECTRUM POLYCORD I RECORDER SYSTEM

Applicant Cardionics, Inc.

K number K862776

View details →

DSH 1986-04-11

MODEL 509A PHYSIOCORDER AMBULATORY RECORDER

Applicant Del Mar Avionics

K number K854269

View details →

DSH 1986-02-26

MODEL MR-35 HOLTER RECORDER

Applicant Oxford Medilog, Inc.

K number K860182

View details →

DSH 1986-02-26

MODEL MR-30 HOLTER RECORDER

Applicant Oxford Medilog, Inc.

K number K860181

View details →

DSH 1985-11-06

MVM 4000 HOLTER IV RECORDER

Applicant Mountain View Medical

K number K853985

View details →

DSH 1985-10-11

CARDIO DATA PACERECORDER PR3

Applicant Cardio Data

K number K853262

View details →

DSH 1985-06-20

SERIES 7000/HOLTER RECORDER

Applicant Pfizer, Inc.

K number K851971

View details →

DSH 1985-06-14

AMBULATORY PH RECORDING DEVICE

Applicant Clinical Data Instruments, Inc.

K number K842349

View details →

DSH 1985-02-14

SPACELABS MODEL 90201 HOLTER RECORDER

Applicant Spacelabs, Inc.

K number K844940

View details →

DSH 1985-01-14

HOLTER CURA-LITE RECORDER

Applicant Cardionostics, Inc.

K number K844977

View details →

DSH 1984-12-11

DEL MAR AVIONICS 509 NEUROCORDER AMBUL

Applicant Del Mar Avionics

K number K841654

View details →

DSH 1984-10-29

CARDIORHYTHM 2000

Applicant Biogenix, Inc.

K number K841472

View details →

DSH 1984-10-24

MINGOGRAF 7

Applicant Siemens Medical Solutions USA, Inc.

K number K841868

View details →

DSH 1984-09-04

CARDIONOSTICS HOLTER DURA-LITE RECORDE

Applicant Cardionostics, Inc.

K number K842954

View details →

DSH 1984-04-17

EVENT TAPE RECORDER 8293

Applicant Aequitron Medical, Inc.

K number K833349

View details →

DSH 1984-04-17

RESPIRATION/8100-HEART RATE RECORDER

Applicant Aequitron Medical, Inc.

K number K833348

View details →

DSH 1984-01-30

CARDIODATA PACE RECORDER

Applicant Cardio Data

K number K834257

View details →

DSH 1983-12-01

HOLTER PERFORMER FEATHER WEIGHT/CASS

Applicant Applied Cardiac Systems

K number K833823

View details →

DSH 1983-11-28

ELECTROCARDIOCORDER RECORDER 453

Applicant Del Mar Avionics

K number K833661

View details →

DSH 1983-10-20

HOLTA-MED RECORDER

Applicant Holta-Med

K number K832395

View details →

DSH 1983-07-28

AMBULATORY ECG EVENT RECORDER

Applicant Brentwood Instruments, Inc.

K number K830907

View details →

DSH 1983-07-07

OMAR

Applicant Oxford Medilog, Inc.

K number K830915

View details →

DSH 1983-05-25

DATA IV AMBULATORY MONITOR

Applicant Cardio-Scan of Texas

K number K831262

View details →

DSH 1983-05-25

RECORDER DMI

Applicant Diagnostic Medical Instruments

K number K830489

View details →

DSH 1983-05-09

CARDIO DATA PACEMAKER RECORDER

Applicant Cardio Data

K number K831184

View details →

DSH 1983-04-12

CHALLENGER #450

Applicant Transmed, Inc.

K number K830519

View details →

DSH 1983-01-14

ALTA II ECG RECORDER

Applicant Scole Engineering Co.

K number K822362

View details →

DSH 1982-12-30

HOLTER KIT MODEL #5000 SERIES

Applicant Andover Medical, Inc.

K number K823414

View details →

DSH 1982-12-30

HOLTER RECORDER & PLAYBACK/ANALYSIS SYS

Applicant Marquette Electronics, Inc.

K number K822818

View details →

DSH 1982-11-03

HOLTER RECORDER

Applicant Agilent Technologies

K number K822970

View details →

DSH 1982-10-04

ALTA III ECG RECORDER

Applicant Scole Engineering Co.

K number K822363

View details →

DSH 1982-06-25

MEDILAC #SR4 & SR 40

Applicant Spelna, Inc.

K number K820256

View details →

DSH 1982-05-28

TRACKER-2 CHANNEL ECG TAPE RECORDER

Applicant Reynolds Medical , Ltd.

K number K821516

View details →

DSH 1982-05-25

CARDIOCASSETTE II #363

Applicant Birtcher Corp.

K number K821453

View details →

DSH 1982-01-29

HOLTER PERFORMER

Applicant Applied Cardiac Systems

K number K813602

View details →

DSH 1981-12-02

EVENT MASTER

Applicant Instruments For Cardiac Research

K number K812920

View details →

DSH 1981-10-20

ECG MEDATAPE-601

Applicant Hospital Equipment Service

K number K812763

View details →

DSH 1981-07-10

CASSETTE READER

Applicant American Edwards Laboratories

K number K811253

View details →

DSH 1981-04-10

PHARMALOG

Applicant Circadian, Inc.

K number K810698

View details →

DSH 1981-01-13

ADVANCEMED HOLTER RECORDERS

Applicant American Edwards Laboratories

K number K803224

View details →

DSH 1981-01-13

ADVANCEMED CCU DOCUMENTOR

Applicant American Edwards Laboratories

K number K803222

View details →

DSH 1980-11-12

MEDICAL MAGNETIC TAPE RECORDER

Applicant Medical Concepts, Inc.

K number K802564

View details →

DSH 1980-08-27

MODEL 9200 VIS-U-SCAN

Applicant Del Mar Avionics

K number K801832

View details →

DSH 1980-05-28

AMBULATORY MONITOR AM-1

Applicant Burdick Corp.

K number K801001

View details →

DSH 1980-02-29

CIRCAMED I

Applicant Circadian, Inc.

K number K800214

View details →

DSH 1979-12-27

MODEL 447 ELECTROCARDIOCORDER

Applicant Del Mar Avionics

K number K792079

View details →

DSH 1979-12-27

MODEL 449 ELECTROCARDIOCORDER

Applicant Del Mar Avionics

K number K792078

View details →

DSH 1979-12-27

MODEL 448 PACERCORDER

Applicant Del Mar Avionics

K number K792076

View details →

DSH 1979-06-01

LIFEPAK 5 MONITOR, CASSETTE, #800923-01

Applicant Physio-Control Corp.

K number K790757

View details →

DSH 1979-06-01

QUICKSCAN HOLTER II

Applicant Intl. Medical, Inc.

K number K790476

View details →

DSH 1979-03-23

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM

Applicant Cambridge Instruments, Inc.

K number K790509

View details →

DSH 1979-02-27

PB-4 REPLAY UNIT

Applicant Oxford Medilog, Inc.

K number K790289

View details →

DSH 1979-02-27

RECORDER, MEDILOG II

Applicant Oxford Medilog, Inc.

K number K790286

View details →

DSH 1978-11-03

RECORDER, HOLTER ELECTROCARDIOGRAM

Applicant Hovik Corp.

K number K781843

View details →

DSH 1977-11-09

CARDIOCASSETTE II

Applicant Cardiodyne, Inc.

K number K772027

View details →

DSH 1977-11-07

RECORDER, DINMAP, MODEL 950

Applicant Applied Medical Research

K number K771932

View details →

DSH 1976-12-28

DYNAMIC RECORDER (DR-10)

Applicant Eldeco

K number K761074

View details →

DSH 1976-08-30

ACCUTAPE 24

Applicant Medcraft Corp.

K number K760508

View details →