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

    TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE

    K Number: K904943 · Decision Apr 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    3
    Review Days
    176

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    Basic Information

    Device Name
    TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
    K Number
    K904943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Arzco Medical Electronics, Inc.
    Date Received
    November 1, 1990
    Decision Date
    April 26, 1991
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by Arzco Medical Electronics, Inc.

    K Number Device Name
    K905831 ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
    K903136 ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER