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

    HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA

    K Number: K864089 · Decision Nov 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA
    K Number
    K864089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hitachi Sales Corporation of America
    Date Received
    October 21, 1986
    Decision Date
    November 7, 1986
    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 Hitachi Sales Corporation of America

    K Number Device Name
    K864088 HITACHI HAND HELD MASSAGER A/C POWERED