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

    Fingertip Pulse Oximeter

    K Number: K210274 · Decision Jul 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    2
    Review Days
    179

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    Basic Information

    Device Name
    Fingertip Pulse Oximeter
    K Number
    K210274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhuhai Linte Medical Instrument Co., Ltd.
    Date Received
    February 1, 2021
    Decision Date
    July 30, 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 Zhuhai Linte Medical Instrument Co., Ltd.

    K Number Device Name
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