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

    The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

    K Number: K161933 · Decision Aug 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    33

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    Basic Information

    Device Name
    The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
    K Number
    K161933
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaz USA, Inc., A Helen of Troy Company
    Date Received
    July 14, 2016
    Decision Date
    August 16, 2016
    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 Kaz USA, Inc., A Helen of Troy Company

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