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

    Med-Link Temp-pulse Oximeter

    K Number: K202743 · Decision Mar 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    14
    Review Days
    164

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    Basic Information

    Device Name
    Med-Link Temp-pulse Oximeter
    K Number
    K202743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Med-Link Electronics Tech Co., Ltd.
    Date Received
    September 18, 2020
    Decision Date
    March 1, 2021
    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 Med-Link Electronics Tech Co., Ltd.

    K Number Device Name
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    K220448 Disposable Non-invasive EEG Sensor
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    K182667 Med-link Temperature Probes
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    Search all 14 clearances from Shenzhen Med-Link Electronics Tech Co., Ltd. →