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

    STARBAND, STARLIGHT

    K Number: K141842 · Decision Oct 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    16
    Review Days
    90

    Basic Information

    Device Name
    STARBAND, STARLIGHT
    K Number
    K141842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ORTHOMERICA PRODUCTS, INC.
    Date Received
    July 8, 2014
    Decision Date
    October 6, 2014
    Product Code
    MVA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVA Orthosis, Cranial

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