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

    CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION

    K Number: K113111 · Decision Dec 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
    K Number
    K113111
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inovo, Inc.
    Date Received
    October 20, 2011
    Decision Date
    December 8, 2011
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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    Other Clearances by Inovo, Inc.

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    K141967 PUREFILL OXYGEN COMPRESSOR
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    K051540 INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
    K031983 INOVO, INC, ECONOMIZER CONSERVING REGULATOR