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

    SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML

    K Number: K113033 · Decision Jun 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    251

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    Basic Information

    Device Name
    SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
    K Number
    K113033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nephron Pharmaceuticals Corp.
    Date Received
    October 12, 2011
    Decision Date
    June 19, 2012
    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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    Other Clearances by Nephron Pharmaceuticals Corp.

    K Number Device Name
    K120051 SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML