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

    PUREFILL OXYGEN COMPRESSOR

    K Number: K141967 · Decision Nov 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    6
    Review Days
    109

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    Basic Information

    Device Name
    PUREFILL OXYGEN COMPRESSOR
    K Number
    K141967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inovo, Inc.
    Date Received
    July 21, 2014
    Decision Date
    November 7, 2014
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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    Other Clearances by Inovo, Inc.

    K Number Device Name
    K113111 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
    K103392 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
    K060751 INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
    K051540 INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
    K031983 INOVO, INC, ECONOMIZER CONSERVING REGULATOR