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

    SURFACE TEMPERATURE SCANNER

    K Number: K873010 · Decision Nov 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    SURFACE TEMPERATURE SCANNER
    K Number
    K873010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Omega Medical Corp.
    Date Received
    August 4, 1987
    Decision Date
    November 17, 1987
    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 Omega Medical Corp.

    K Number Device Name
    K882949 TYMPANIC TEMPERATURE SCANNER