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

    BLOOD PRESSURE MONITOR, ARTERIAL

    K Number: K780128 · Decision Jan 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    22
    Review Days
    7

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    Basic Information

    Device Name
    BLOOD PRESSURE MONITOR, ARTERIAL
    K Number
    K780128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Research
    Date Received
    January 24, 1978
    Decision Date
    January 31, 1978
    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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