BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002

    K Number: K000653 · Decision Aug 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
    K Number
    K000653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5165
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonox Medical Corp.
    Date Received
    February 28, 2000
    Decision Date
    August 4, 2000
    Product Code
    MRN
    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
    MRN Apparatus, Nitric Oxide Delivery

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