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

    VIANOX DELIVERY SYSTEM, MODEL I

    K Number: K023014 · Decision Aug 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    338

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    Basic Information

    Device Name
    VIANOX DELIVERY SYSTEM, MODEL I
    K Number
    K023014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2380
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonox Medical, Inc.
    Date Received
    September 10, 2002
    Decision Date
    August 14, 2003
    Product Code
    MRP
    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
    MRP Analyzer, Nitric Oxide

    Other Clearances by Pulmonox Medical, Inc.

    K Number Device Name
    K033779 VIANOX DELIVERY SYSTEM, MODEL II