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

    Infrared Thermometer Model Number RN-60A,RN-60B

    K Number: K200471 · Decision Jun 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    114

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    Basic Information

    Device Name
    Infrared Thermometer Model Number RN-60A,RN-60B
    K Number
    K200471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Received
    February 26, 2020
    Decision Date
    June 19, 2020
    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 Ningbo Ranor Medical Science & Technology Co., Ltd.

    K Number Device Name
    K251143 Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
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