BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    CueSee Hypoxic

    K Number: K152553 · Decision Apr 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    7
    Review Days
    227

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    Basic Information

    Device Name
    CueSee Hypoxic
    K Number
    K152553
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurotrol B.V.
    Date Received
    September 8, 2015
    Decision Date
    April 22, 2016
    Product Code
    JJS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

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