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

    INOMAX DS (DELIVERY SYSTEM), MODEL 10003

    K Number: K092545 · Decision Mar 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    203

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    Basic Information

    Device Name
    INOMAX DS (DELIVERY SYSTEM), MODEL 10003
    K Number
    K092545
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5165
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ino Therapeutics, LLC
    Date Received
    August 19, 2009
    Decision Date
    March 10, 2010
    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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    Other Clearances by Ino Therapeutics, LLC

    K Number Device Name
    K090958 INOMAX DS (DELIVERY SYSTEM)
    K081691 INOMAX DS (DELIVERY SYSTEM)
    K071516 INOMAX DS
    K070867 INOMAX DS (DELIVERY SYSTEM), MODEL 10003