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

    LIQUID CRYSTAL THERM. 8 EVENT MONITOR

    K Number: K802778 · Decision Jan 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    65

    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
    LIQUID CRYSTAL THERM. 8 EVENT MONITOR
    K Number
    K802778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Djinnii Industires, Inc.
    Date Received
    November 5, 1980
    Decision Date
    January 9, 1981
    Product Code
    KPD
    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
    KPD Strip, Temperature, Forehead, Liquid Crystal

    Similar 510(k) Clearances

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

    E-Z TEMP II

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEMP MARQ TEMPERATURE TREND INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FEVER LINE AND FEVER LINE PLUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OMNI THERM TEMPERATURE MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEMPALERT LIQUID CRYSTAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEMPTREND PEDS AXILLARY TEMP. INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all