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

    MEDISONIC PNEU-NEB

    K Number: K896192 · Decision Jan 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    MEDISONIC PNEU-NEB
    K Number
    K896192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medisonic U.S.A., Inc.
    Date Received
    October 25, 1989
    Decision Date
    January 3, 1990
    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 Medisonic U.S.A., Inc.

    K Number Device Name
    K924577 MEDIVAC
    K923660 MEDISONIC OXYGEN FLOW CONTROLLER
    K901114 MEDISONIC HUMDIFIER/INHALER
    K894961 MEDISONIC ULTRA-SONIC INHALER