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

    SKYTRON SKYBOOM SERIES

    K Number: K950192 · Decision Apr 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    34
    Applicant Total
    19
    Review Days
    75

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    Basic Information

    Device Name
    SKYTRON SKYBOOM SERIES
    K Number
    K950192
    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
    Skytron, Div. the Kmw Group, Inc.
    Date Received
    January 18, 1995
    Decision Date
    April 3, 1995
    Product Code
    FQO
    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
    FQO Table, Operating-Room, Ac-Powered

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