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

    EXTERNAL PULSE OXIMETER

    K Number: K141024 · Decision Jan 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    29
    Review Days
    267

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    Basic Information

    Device Name
    EXTERNAL PULSE OXIMETER
    K Number
    K141024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technololgy Co., Ltd.
    Date Received
    April 21, 2014
    Decision Date
    January 13, 2015
    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 Beijing Choice Electronic Technololgy Co., Ltd.

    K Number Device Name
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    K141128 FINGERTIP PULSE OXIMETER
    K140682 FINGERTIP PULSE OXIMETER
    K131047 FINGERTIP PULSE OXIMETER
    K130947 FINGERTIP PULSE OXIMETER
    K123871 FINGERTIP PULSE OXIMETER
    K122046 WRIST PULSE OXIMETER
    K112622 HANDHELD ECG MONITOR
    Search all 29 clearances from Beijing Choice Electronic Technololgy Co., Ltd. →