ClearanceBrief
Panels › Cardiovascular › Product code DXH · Class 2

Transmitters And Receivers, Electrocardiograph, Telephone

Regulation 870.2920

4510(k)s in 12 months (297 all time)
1recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in DXH

Company510(k)sRecalls
Card Guard Scientific Survival , Ltd.280
Instromedix170
Medtronic Vascular150
AliveCor, Inc.100
Universal Medical, Inc.80
Survival Technology, Inc.70
Paceart, Inc.60
Aerotel, Ltd.50
Intermedics, Inc.50
Physio-Control Corp.50
Decided510(k)Device and applicantCode
Oct 26, 1984K840032TELEPHONE RECEIVERS R101 R111
Biometric Products, Inc.
DXH
May 9, 1984K834034MODEM ACCESSORY FOR EPI CARDIA SYS
Medicomp, Inc.
DXH
Feb 17, 1984K832951MEMORY LOOP TRANSMITTER #121
Biometric Products, Inc.
DXH
Aug 12, 1983K831443PACELINE PATIENT TRANSMITTER MODEL 324
Pacesetter Systems
DXH
Jul 26, 1983K830903CARDIO ARRHYTHMIA TRANSMITTER C.A.T
Cardio Technology , Ltd.
DXH
Jul 19, 1983K831092PECGASYS REMOTE TRANSMISSION UNIT
Datamedix
DXH
May 18, 1983K830254LIFE LINE
Kb & Assoc.
DXH
May 9, 1983K830477CARDIOMEMO III
Instromedix, Inc.
DXH
Jan 21, 1983K830028SIRECUST 456
Analogic Corp.
DXH
Nov 1, 1982K822955MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
Medtronic Vascular
DXH
Jul 8, 1982K821726MODEL 535-02 TRACE-A-PACE TRANSMITTER
Intermedics, Inc.
DXH
Apr 29, 1982K820986EKG MONITORS, VARIOUS MODELS
Dart Medical Equipment
DXH
Apr 21, 1982K820904EKG TELEPHONE CONVERTER
Dart Medical Equipment
DXH
Apr 16, 1982K820452PHONOTRACE 2000
Lowrance Electronics, Inc.
DXH
Apr 14, 1982K820828SAMM
Dart Medical Equipment
DXH
Feb 12, 1982K820276TELESCAN T-30
Telescan Medical Systems
DXH
Jan 18, 1982K812793P.E.T.
Hospital Equipment Service
DXH
Nov 16, 1981K812755MODEL 535-03 TRACE A PACE
Intermedics, Inc.
DXH
Oct 23, 1981K812703MODEL 9408 A TELETRACE
Medtronic Vascular
DXH
Sep 23, 1981K811464MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
Intermedics, Inc.
DXH
Aug 3, 1981K811758ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR
Powers Medical Systmes
DXH
Jun 30, 1981K811512TELETRACE TELEPHONE EKG SYSTEM
Medtronic Vascular
DXH
May 1, 1981K810872EEG TELEPHONE RECEIVER MODEL #AFR-J
Telediagnostic Systems, Inc.
DXH
May 1, 1981K810608TRANSMITTER & RECEIVERS, TELEPHONE, ELEC
Heart Check Systems, Inc.
DXH
Jan 22, 1981K803315CRITERION II RHYTHM PROFILE MONITOR
Dart Medical Equipment
DXH
Jan 22, 1981K802717HP MODEL 4710A ECG TRANSMITTER
Hewlett-Packard Co.
DXH
Sep 26, 1980K802089CARDIOTRAK
Cardiac Pacemakers, Inc.
DXH
Aug 7, 1980K801700UNI-RECORD I
Bd Becton Dickinson Vacutainer Systems Preanalytic
DXH
Dec 5, 1979K792359MEDTRONIC MODEL 9407 TELETRACE TRANSMITT
Medtronic Vascular
DXH
Nov 21, 1979K792246MEDTRONIC MODEL 9408 TELETRACE TRANSMIT
Medtronic Vascular
DXH
Oct 2, 1979K791778MEDTRONIC MODEL 9410 TELETRACE RECEIVER
Medtronic Vascular
DXH
Dec 29, 1978K782076HT-110 MICROMINI
Health Tech
DXH
Dec 21, 1978K782059TRANSMITTER, TR-1 ECG
Burdick Corp.
DXH
Dec 13, 1978K781986TRANSMITTER, MODEL 9406 AND 9401
Medtronic Vascular
DXH
Mar 21, 1978K780158TELETRACE TELEPHONE EKG TRANSMITTER
Medtronic Vascular
DXH
Mar 9, 1978K772350PATIENT ALERT MODEL 555
Intermedics, Inc.
DXH
Feb 2, 1978K772186ELECTROCARDIOGRAPH TRANSMITTER, 536
Intermedics, Inc.
DXH
Dec 8, 1977K772178PACER MONITOR, PULSE WIDTH
Survival Technology, Inc.
DXH
Sep 20, 1977K771648COMPUTER ECG TERMINAL
Compumed, Inc.
DXH
Jun 2, 1977K770949COMPUTER ECG TELE. TRANSMISSION TERMINAL
The Okun Co.
DXH
Feb 16, 1977K770264PACEGUARD
Cardio Data
DXH
Jan 28, 1977K760857TR-3 TRANSMITTER
Burdick Corp.
DXH
Jan 6, 1977K7613183038 OPTION B-COMPUT. TRANS. TERMINAL
Cambridge Instruments, Inc.
DXH
Dec 28, 1976K761073POCKET TRANSMITTER (PT-10)
Eldeco
DXH
Dec 9, 1976K761066ECG MONITOR (TELEPHONE ECG TRANSMITTER)
Physio-Control Corp.
DXH
Sep 10, 1976K760564DEMODULATOR SERIES 1400
Physio-Control Corp.
DXH
Sep 10, 1976K760563ECG MODULATOR
Physio-Control Corp.
DXH

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