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

    SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

    K Number: K123614 · Decision Mar 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    12
    Review Days
    108

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    Basic Information

    Device Name
    SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
    K Number
    K123614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trudell Medical Intl.
    Date Received
    November 23, 2012
    Decision Date
    March 11, 2013
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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