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

    SuperNO2VA Et Device

    K Number: K173147 · Decision Jun 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    2
    Review Days
    264

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    Basic Information

    Device Name
    SuperNO2VA Et Device
    K Number
    K173147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Revolutionary Medical Devices, Inc.
    Date Received
    September 29, 2017
    Decision Date
    June 20, 2018
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Revolutionary Medical Devices, Inc.

    K Number Device Name
    K163277 SuperNO2VA Device