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

    DIGITRON ELECTRONIC THERMOMETERS - 4700

    K Number: K812387 · Decision Sep 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    DIGITRON ELECTRONIC THERMOMETERS - 4700
    K Number
    K812387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ercona Corp.
    Date Received
    August 20, 1981
    Decision Date
    September 9, 1981
    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 Ercona Corp.

    K Number Device Name
    K772424 RYUSEI