BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PNEUMATIC VITRECTOMY CONTROL UNIT

    K Number: K781471 · Decision Nov 8, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    1
    Review Days
    72

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    Basic Information

    Device Name
    PNEUMATIC VITRECTOMY CONTROL UNIT
    K Number
    K781471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Helfgott Medical Instruments
    Date Received
    August 28, 1978
    Decision Date
    November 8, 1978
    Product Code
    HQE
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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