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

    DISPOSABLE TEMPERATURE PROBE COVER

    K Number: K801366 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    DISPOSABLE TEMPERATURE PROBE COVER
    K Number
    K801366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Bib, Inc.
    Date Received
    June 10, 1980
    Decision Date
    July 28, 1980
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Bib, Inc.

    K Number Device Name
    K830916 VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
    K801389 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
    K800596 VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
    K800782 PACE-PULSE/COMPUTRAC