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

    MODEL 412 ELECTROFLUIDIC MANOMETER

    K Number: K800222 · Decision Feb 29, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    16
    Review Days
    25

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    Basic Information

    Device Name
    MODEL 412 ELECTROFLUIDIC MANOMETER
    K Number
    K800222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Med-Tek Corp.
    Date Received
    February 4, 1980
    Decision Date
    February 29, 1980
    Product Code
    DXW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXW System, Phonocatheter, Intracavitary

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