BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CO Check Pro, CO Screen

    K Number: K171129 · Decision Mar 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    319

    Basic Information

    Device Name
    CO Check Pro, CO Screen
    K Number
    K171129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MD Diagnostics Limited
    Date Received
    April 17, 2017
    Decision Date
    March 2, 2018
    Product Code
    CCJ
    Advisory Committee
    Anesthesiology
    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
    CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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