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

    ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER

    K Number: K983736 · Decision Nov 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
    K Number
    K983736
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brasamerica Medical Equipment, Inc.
    Date Received
    October 22, 1998
    Decision Date
    November 10, 1998
    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 Brasamerica Medical Equipment, Inc.

    K Number Device Name
    K972371 ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR