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

    SELF-CONTAINED MOBILE OPHTHAL. OPER. .

    K Number: K822427 · Decision Sep 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    33

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    Basic Information

    Device Name
    SELF-CONTAINED MOBILE OPHTHAL. OPER. .
    K Number
    K822427
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgi-Quip Inc.U
    Date Received
    August 12, 1982
    Decision Date
    September 14, 1982
    Product Code
    FSE
    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
    FSE Table, Operating-Room, Manual

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    Other Clearances by Surgi-Quip Inc.U

    K Number Device Name
    K841115 CHARLES/MCINTYRE GIANT BREAK TABLE
    K841116 MOBILE OPHTHALMIC OPERATING TABLE
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    K832887 ELECTRONIC UNIT
    K822554 CEMENT EXTRACTION INSTRUMENTATION
    K822426 MCINTYRE MICROSCOPE STAND
    K822428 SURGI-QUIP MICROSCOPE STAND