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510(k) Data Aggregation

    K Number
    K063716
    Device Name
    AEROSOL SYSTEM
    Manufacturer
    AMICI, INC.
    Date Cleared
    2007-12-28

    (379 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMICI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.
    Device Description
    The AeroSol™ Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas of the lungs for diagnostic imaging. It has an injection site, a nebulizer, aerosol conduit, aerosol trapping and is manufactured of materials and components used in previously cleared 510(k) devices.
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    K Number
    K952910
    Device Name
    THE SWIRLER NEBULIZER
    Manufacturer
    AMICI, INC.
    Date Cleared
    1997-03-19

    (632 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMICI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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