BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PODOSCOPE

    K Number: K864499 · Decision Feb 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    82

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    Basic Information

    Device Name
    PODOSCOPE
    K Number
    K864499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Broadwest Corp.
    Date Received
    November 14, 1986
    Decision Date
    February 4, 1987
    Product Code
    IKE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKE Transducer, Miniature Pressure

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