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

    POPE AMBULATORY HALO VEST

    K Number: K791350 · Decision Aug 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    POPE AMBULATORY HALO VEST
    K Number
    K791350
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hospital Products Co.
    Date Received
    July 17, 1979
    Decision Date
    August 3, 1979
    Product Code
    IQF
    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
    IQF Orthosis, Cervical-Thoracic, Rigid

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