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

    SKYTRON ELITE 6000 & 6001 SURGICAL TABLES

    K Number: K853480 · Decision Sep 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    17
    Applicant Total
    19
    Review Days
    23

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    Basic Information

    Device Name
    SKYTRON ELITE 6000 & 6001 SURGICAL TABLES
    K Number
    K853480
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Skytron, Div. the Kmw Group, Inc.
    Date Received
    August 20, 1985
    Decision Date
    September 12, 1985
    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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