BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    REMOTE INFRARED THERMOMETER, MODEL RC002

    K Number: K090361 · Decision Oct 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    1
    Review Days
    238

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    Basic Information

    Device Name
    REMOTE INFRARED THERMOMETER, MODEL RC002
    K Number
    K090361
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rycom Electron Technology Limited
    Date Received
    February 12, 2009
    Decision Date
    October 8, 2009
    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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