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

    Ox-Imager CS

    K Number: K153426 · Decision Dec 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    392

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    Basic Information

    Device Name
    Ox-Imager CS
    K Number
    K153426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Modulated Imaging, Inc.
    Date Received
    November 25, 2015
    Decision Date
    December 21, 2016
    Product Code
    MUD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUD Oximeter, Tissue Saturation

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