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

    NARCO TLECARE MINIATURE PRESSURE DOME

    K Number: K810431 · Decision Mar 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    9
    Review Days
    20

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    Basic Information

    Device Name
    NARCO TLECARE MINIATURE PRESSURE DOME
    K Number
    K810431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Narco Bio-Systems
    Date Received
    February 19, 1981
    Decision Date
    March 11, 1981
    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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