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

    Reusable Temperature Probe

    K Number: K182751 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    6
    Review Days
    343

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    Basic Information

    Device Name
    Reusable Temperature Probe
    K Number
    K182751
    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 Caremed Medical Technology Co., Ltd.
    Date Received
    September 28, 2018
    Decision Date
    September 6, 2019
    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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    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

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    Other Clearances by Shenzhen Caremed Medical Technology Co., Ltd.

    K Number Device Name
    K191279 Disposable SpO2 Sensor
    K182755 Disposable Temperature Probe
    K182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
    K153184 Caremed Reusable & Disposable SPO2 Sensors
    K153188 Caremed patient cable and leadwires