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510(k) Data Aggregation

    K Number
    K012271
    Device Name
    ACUTEVENTILATOR
    Manufacturer
    IMPOEX INTERNATIONAL, LTD.
    Date Cleared
    2002-10-04

    (442 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPOEX INTERNATIONAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.
    Device Description
    a pumping apparatus of the bellows type, which is adapted for artificial respiration
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