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

    KOO SMALL VOLUME NEBULIZER (SVN)

    K Number: K112041 · Decision Dec 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    KOO SMALL VOLUME NEBULIZER (SVN)
    K Number
    K112041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koo (Shanghai) Industries Co., Ltd.
    Date Received
    July 18, 2011
    Decision Date
    December 22, 2011
    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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