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

    ROBERTSON OBTURATION MONITOR INSUFFLA

    K Number: K802374 · Decision Nov 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    ROBERTSON OBTURATION MONITOR INSUFFLA
    K Number
    K802374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Endotek Corp.
    Date Received
    September 29, 1980
    Decision Date
    November 24, 1980
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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    Other Clearances by Endotek Corp.

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