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

    VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR

    K Number: K830916 · Decision Jul 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    5
    Review Days
    107

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    Basic Information

    Device Name
    VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
    K Number
    K830916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bib, Inc.
    Date Received
    March 22, 1983
    Decision Date
    July 7, 1983
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Bib, Inc.

    K Number Device Name
    K801366 DISPOSABLE TEMPERATURE PROBE COVER
    K801389 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
    K800596 VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
    K800782 PACE-PULSE/COMPUTRAC