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

    SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR

    K Number: K983406 · Decision Oct 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
    K Number
    K983406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Banta Healthcare Group, Ltd.
    Date Received
    September 28, 1998
    Decision Date
    October 19, 1998
    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 Banta Healthcare Group, Ltd.

    K Number Device Name
    K042580 TIDI BRAND STERILIZATION WRAP