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

    BREMER IMAGING TONGS-MRI MODEL

    K Number: K924606 · Decision Sep 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    363

    Basic Information

    Device Name
    BREMER IMAGING TONGS-MRI MODEL
    K Number
    K924606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BREMER MEDICAL, INC.
    Date Received
    September 11, 1992
    Decision Date
    September 9, 1993
    Product Code
    HAX
    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
    HAX Tong, Skull For Traction

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