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

    BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER

    K Number: K992468 · Decision Oct 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    7
    Review Days
    89

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    Basic Information

    Device Name
    BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
    K Number
    K992468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braun GmbH
    Date Received
    July 23, 1999
    Decision Date
    October 20, 1999
    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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    K Number Device Name
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    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
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