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

    Digital thermometer, Model DT101, DT102

    K Number: K213746 · Decision Apr 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    Digital thermometer, Model DT101, DT102
    K Number
    K213746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Berrcom Medical Device Co., Ltd.
    Date Received
    November 29, 2021
    Decision Date
    April 5, 2022
    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 Guangzhou Berrcom Medical Device Co., Ltd.

    K Number Device Name
    K214077 Digital Thermometer, Model: DT007, DT008
    K213084 Ear Thermometer, Model ET005, ET008, ET009
    K213079 Ear Thermometer, Model ET001
    K213082 Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
    K191570 Infrared Thermometer Model MD-H30