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

    STANDARD HEALTH BIKE MODEL 019

    K Number: K791866 · Decision Oct 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    13

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    Basic Information

    Device Name
    STANDARD HEALTH BIKE MODEL 019
    K Number
    K791866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Battle Creek Equipment Co.
    Date Received
    September 21, 1979
    Decision Date
    October 4, 1979
    Product Code
    ISD
    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
    ISD Exerciser, Measuring

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