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

    BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER

    K Number: K060006 · Decision Jan 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
    K Number
    K060006
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braun GmbH
    Date Received
    January 3, 2006
    Decision Date
    January 31, 2006
    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 Braun GmbH

    K Number Device Name
    K061351 ORAL-B SONIC COMPLETE
    K061199 ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
    K031928 BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
    K012035 BRAUN PRECISION SENSOR PRO, MODEL BP 2590
    K003732 BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
    K992468 BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER