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

    SIDE RAIL PADS

    K Number: K823821 · Decision Jan 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    221
    Registration Numbers
    221
    Same Product Code
    38
    Applicant Total
    56
    Review Days
    35

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    Basic Information

    Device Name
    SIDE RAIL PADS
    K Number
    K823821
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5120
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    December 17, 1982
    Decision Date
    January 21, 1983
    Product Code
    FNJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FNJ Bed, Manual

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