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

    VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR

    K Number: K800596 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    126

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
    K Number
    K800596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bib, Inc.
    Date Received
    March 17, 1980
    Decision Date
    July 21, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Bib, Inc.

    K Number Device Name
    K830916 VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
    K801366 DISPOSABLE TEMPERATURE PROBE COVER
    K801389 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
    K800782 PACE-PULSE/COMPUTRAC