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

    MICROTYNE UNIT

    K Number: K760913 · Decision Nov 12, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    MICROTYNE UNIT
    K Number
    K760913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Transmed, Inc.
    Date Received
    September 24, 1976
    Decision Date
    November 12, 1976
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Transmed, Inc.

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    K830519 CHALLENGER #450