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

    MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO

    K Number: K081870 · Decision Jul 31, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    30
    Review Days
    30

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    Basic Information

    Device Name
    MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
    K Number
    K081870
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Healthcare Finland Oy
    Date Received
    July 1, 2008
    Decision Date
    July 31, 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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