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

    T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE

    K Number: K894757 · Decision Sep 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    12
    Review Days
    53

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    Basic Information

    Device Name
    T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
    K Number
    K894757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Louisville Laboratories, Inc.
    Date Received
    July 27, 1989
    Decision Date
    September 18, 1989
    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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