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

    BLOOD PRESSURE MONITORING DEVICES

    K Number: K822614 · Decision Sep 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    26
    Review Days
    22

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    Basic Information

    Device Name
    BLOOD PRESSURE MONITORING DEVICES
    K Number
    K822614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    August 30, 1982
    Decision Date
    September 21, 1982
    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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