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

    Wireless Smart Thermometer

    K Number: K233192 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    190

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    Basic Information

    Device Name
    Wireless Smart Thermometer
    K Number
    K233192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Famidoc Technology Company Limited
    Date Received
    September 28, 2023
    Decision Date
    April 5, 2024
    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 Famidoc Technology Company Limited

    K Number Device Name
    K222887 Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
    K191673 Upper Arm Blood Pressure Monitor