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

    Caremed Reusable & Disposable SPO2 Sensors

    K Number: K153184 · Decision Jan 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    6
    Review Days
    428

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    Basic Information

    Device Name
    Caremed Reusable & Disposable SPO2 Sensors
    K Number
    K153184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Caremed Medical Technology Co., Ltd.
    Date Received
    November 3, 2015
    Decision Date
    January 4, 2017
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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

    K Number Device Name
    K191279 Disposable SpO2 Sensor
    K182751 Reusable Temperature Probe
    K182755 Disposable Temperature Probe
    K182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
    K153188 Caremed patient cable and leadwires