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

    PRESS-O-TEST

    K Number: K822102 · Decision Nov 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    2
    Review Days
    131

    Basic Information

    Device Name
    PRESS-O-TEST
    K Number
    K822102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    MEDI-SWISS CORP.
    Date Received
    July 16, 1982
    Decision Date
    November 24, 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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    Other Clearances by MEDI-SWISS CORP.

    K Number Device Name
    K904298 EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR