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

    AeroEclipse* ONE BAN

    K Number: K200063 · Decision Jul 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    186

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    Basic Information

    Device Name
    AeroEclipse* ONE BAN
    K Number
    K200063
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trudell Medical International
    Date Received
    January 13, 2020
    Decision Date
    July 17, 2020
    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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