BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

    K Number: K903136 · Decision Jan 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    3
    Review Days
    185

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    Basic Information

    Device Name
    ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER
    K Number
    K903136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Arzco Medical Electronics, Inc.
    Date Received
    July 17, 1990
    Decision Date
    January 18, 1991
    Product Code
    DRF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Arzco Medical Electronics, Inc.

    K Number Device Name
    K904943 TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
    K905831 ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH