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

    BARO/TRAC II & VITA/TRAC, VITAL SIGN MON

    K Number: K801389 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
    K Number
    K801389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bib, Inc.
    Date Received
    June 13, 1980
    Decision Date
    July 28, 1980
    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 Bib, Inc.

    K Number Device Name
    K830916 VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
    K801366 DISPOSABLE TEMPERATURE PROBE COVER
    K800596 VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
    K800782 PACE-PULSE/COMPUTRAC