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

    TERPERATUR SENSING DEVICE

    K Number: K802607 · Decision Nov 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    TERPERATUR SENSING DEVICE
    K Number
    K802607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Burditt & Calkins-Siemens-Elema
    Date Received
    October 21, 1980
    Decision Date
    November 19, 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 Burditt & Calkins-Siemens-Elema

    K Number Device Name
    K833519 PULSE GENERATOR MODEL 688
    K833155 RAYDEN MEDICAL MINI PULSE VOLUME RECORD
    K830344 SIEMENS-ELMA PULSE GENERATOR #718
    K823435 MON-A-THERM MYOCARDIAL TEMP. SENSOR
    K823591 AMEDA HAND BREAST PUMP
    K822239 COAXIAL BIPOLAR PACING ELECTRODE
    K821712 INFORMED REMOTE FIELD UNIT MODEL IFM1000
    K803111 ERECTAID
    K760787 LIBERATOR/STROLLER