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

    IHEALTH FINGERTIP PULSE OXIMETER

    K Number: K131111 · Decision Sep 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    51
    Review Days
    145

    Basic Information

    Device Name
    IHEALTH FINGERTIP PULSE OXIMETER
    K Number
    K131111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ANDON HEALTH CO.,LTD
    Date Received
    April 19, 2013
    Decision Date
    September 11, 2013
    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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