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

    NO TOUCH+FOREHEAD NTF 3000 THERMOMETER

    K Number: K134043 · Decision May 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    141

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    Basic Information

    Device Name
    NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
    K Number
    K134043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaz USA, Inc (A Subsidiaryof Kaz Inc)
    Date Received
    December 31, 2013
    Decision Date
    May 21, 2014
    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 Subsidiaryof Kaz Inc)

    K Number Device Name
    K103800 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
    K101747 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE