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

    DYNASTY GC 12550 (GELL/CELL)

    K Number: K942310 · Decision Nov 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    63
    Applicant Total
    5
    Review Days
    178

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    Basic Information

    Device Name
    DYNASTY GC 12550 (GELL/CELL)
    K Number
    K942310
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Foley & Lardner
    Date Received
    May 13, 1994
    Decision Date
    November 7, 1994
    Product Code
    KNN
    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
    KNN Components, Wheelchair

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