BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Assurance Alar / Nasal SpO2 Sensor

    K Number: K143216 · Decision Mar 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    2
    Review Days
    127

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    Basic Information

    Device Name
    Assurance Alar / Nasal SpO2 Sensor
    K Number
    K143216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xhale, Inc.
    Date Received
    November 10, 2014
    Decision Date
    March 17, 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 Xhale, Inc.

    K Number Device Name
    K171423 Nasal Alar SpO2 Sensor