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

    HEAD-SPINE STABILIZER HSS-1

    K Number: K844549 · Decision Mar 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    HEAD-SPINE STABILIZER HSS-1
    K Number
    K844549
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1920
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Imaging Accessories, Inc.
    Date Received
    November 21, 1984
    Decision Date
    March 1, 1985
    Product Code
    IWY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IWY Holder, Head, Radiographic

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    Other Clearances by Imaging Accessories, Inc.

    K Number Device Name
    K844926 HEAD-SPINE STABILIZER HSS-1