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

    APK SPO2 PULSE OXIMETER SENSOR

    K Number: K082846 · Decision Apr 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    186

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    Basic Information

    Device Name
    APK SPO2 PULSE OXIMETER SENSOR
    K Number
    K082846
    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 29, 2008
    Decision Date
    April 3, 2009
    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
    K172981 Reusable SpO2 Sensors, Disposable SpO2 Sensors
    K170536 ECG Disposable Lead Wire
    K102825 BLOOD PRESSURE CUFF