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

    INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22

    K Number: K063291 · Decision Nov 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    20

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    Basic Information

    Device Name
    INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
    K Number
    K063291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choice Smart Health Care Co. , Ltd.
    Date Received
    November 1, 2006
    Decision Date
    November 21, 2006
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Choice Smart Health Care Co. , Ltd.

    K Number Device Name
    K062952 C300 SERIES AIR NEBULIZER COMPRESSOR
    K062016 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES