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

    AUTOMATIC ELECTRONIC SPHYMOMONOMETER

    K Number: K790537 · Decision May 8, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    1
    Review Days
    49

    Basic Information

    Device Name
    AUTOMATIC ELECTRONIC SPHYMOMONOMETER
    K Number
    K790537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    HEALTHCARE ENTERPRISES, INC.
    Date Received
    March 20, 1979
    Decision Date
    May 8, 1979
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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