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

    OPT80 THE TRANSPORTABLE (OPT80)

    K Number: K972810 · Decision Aug 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    OPT80 THE TRANSPORTABLE (OPT80)
    K Number
    K972810
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4960
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O.P.T. USA, Inc.
    Date Received
    July 28, 1997
    Decision Date
    August 26, 1997
    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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