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

    FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL

    K Number: K082641 · Decision Nov 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    12
    Review Days
    60

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    Basic Information

    Device Name
    FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
    K Number
    K082641
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    September 11, 2008
    Decision Date
    November 10, 2008
    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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