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

    EXACON THERMOMETER SYSTEM 8000

    K Number: K821555 · Decision Aug 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    83

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    Basic Information

    Device Name
    EXACON THERMOMETER SYSTEM 8000
    K Number
    K821555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sat Export Engineering & Trading
    Date Received
    May 25, 1982
    Decision Date
    August 16, 1982
    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 Sat Export Engineering & Trading

    K Number Device Name
    K821556 EXACON TEMP. PROBES SYSTEM 8000-#TH-103
    K820153 EXACON SCIENTIFIC INSTRUMENTS APS