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510(k) Data Aggregation

    K Number
    K970844
    Device Name
    ATOMISOR
    Date Cleared
    1997-11-13

    (251 days)

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

    MEDICAL CONSULTING SERVICE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ATOMISOR AL + NL9 NEBULIZER is an aerosol generator for the delivery of aerosol to the airways. Because they have been designed to be operated together, the ATOMISOR NL9 nebulizer and the ATOMISOR AL compressor should never be used separately.
    Device Description
    The ATOMISOR AL is a small and easy to use portable compressor for jet nebulizer aerosol generator. The pump inside is a diaphragm pump and the casing of the compressor is made of metal with a plastic carrying handle on top. In order to ease its' transportation, in case of rental for example, the ATOMISOR AL can be sold with a PVC carrying case in which both the compressor and the nebulizer can be placed. When used, the compressor is removed from the carrying-case.
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