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

    DURA-BOARD ARMBOARD

    K Number: K964273 · Decision Jan 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    17
    Applicant Total
    5
    Review Days
    72

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    Basic Information

    Device Name
    DURA-BOARD ARMBOARD
    K Number
    K964273
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allen Medical Systems, Inc.
    Date Received
    October 28, 1996
    Decision Date
    January 8, 1997
    Product Code
    GDC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDC Table, Operating-Room, Electrical

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