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

    OXFORD OPTRONIX MPM 3S

    K Number: K914397 · Decision Nov 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    412

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    Basic Information

    Device Name
    OXFORD OPTRONIX MPM 3S
    K Number
    K914397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dia-Stron, Ltd.
    Date Received
    October 1, 1991
    Decision Date
    November 16, 1992
    Product Code
    FTI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTI Lamp, Endoscope, Incandescent

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