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

    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

    K Number: K243000 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
    K Number
    K243000
    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 Medke Technology Co., Ltd.
    Date Received
    September 26, 2024
    Decision Date
    June 20, 2025
    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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