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

    AS-3XX Series Fingertip Pulse Oximeter

    K Number: K180685 · Decision Nov 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    2
    Review Days
    259

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    Basic Information

    Device Name
    AS-3XX Series Fingertip Pulse Oximeter
    K Number
    K180685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiamen Acurio Instruments Co., Ltd.
    Date Received
    March 15, 2018
    Decision Date
    November 29, 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 Xiamen Acurio Instruments Co., Ltd.

    K Number Device Name
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