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

    Reusable SpO2 Sensors, Disposable SpO2 Sensors

    K Number: K172981 · Decision Jun 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    254

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    Basic Information

    Device Name
    Reusable SpO2 Sensors, Disposable SpO2 Sensors
    K Number
    K172981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    APK Technology Co., Ltd.
    Date Received
    September 27, 2017
    Decision Date
    June 8, 2018
    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 APK Technology Co., Ltd.

    K Number Device Name
    K250425 Ultraviolet Phototherapy Device
    K170536 ECG Disposable Lead Wire
    K102825 BLOOD PRESSURE CUFF
    K082846 APK SPO2 PULSE OXIMETER SENSOR