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

    NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER

    K Number: K041082 · Decision Sep 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    22
    Review Days
    134

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    Basic Information

    Device Name
    NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
    K Number
    K041082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    April 26, 2004
    Decision Date
    September 7, 2004
    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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