BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SuperNO2VA Device

    K Number: K163277 · Decision Oct 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    326

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    Basic Information

    Device Name
    SuperNO2VA Device
    K Number
    K163277
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5550
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Revolutionary Medical Devices, Inc.
    Date Received
    November 21, 2016
    Decision Date
    October 13, 2017
    Product Code
    BSJ
    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
    BSJ Mask, Gas, Anesthetic

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    Other Clearances by Revolutionary Medical Devices, Inc.

    K Number Device Name
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