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

    TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30

    K Number: K872596 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    89
    Review Days
    90

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    Basic Information

    Device Name
    TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
    K Number
    K872596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Edwards Laboratories
    Date Received
    July 2, 1987
    Decision Date
    September 30, 1987
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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