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

    Reusable Temperature Probe, Disposable Temperature Probe

    K Number: K223807 · Decision Aug 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    248

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    Basic Information

    Device Name
    Reusable Temperature Probe, Disposable Temperature Probe
    K Number
    K223807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Sino-K Medical Technology Co.,Ltd
    Date Received
    December 20, 2022
    Decision Date
    August 25, 2023
    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 Shenzhen Sino-K Medical Technology Co.,Ltd

    K Number Device Name
    K231961 NIBPCuff
    K192608 Disposable SpO2 Sensor