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    K Number
    K090652
    Device Name
    ALPHA DUO LAP INSUFFLATOR
    Manufacturer
    HIPPOKRATEC GMBH
    Date Cleared
    2009-09-25

    (198 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIPPOKRATEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with CO2 gas for diagnostic or operative Laparoscopy.
    Device Description
    The Laparoscopic Insufflator ALPHA DUO LAP with the following model variants S.2916.00 II, S.2920.00 II, S.2925.00 II, S.2930.00 II, S.2945.00 II" is a microprocessor controlled device, designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and/or therapeutic laparoscopic procedures. The maximum flow delivery capability depends on the indexed ( performance ) type and ranges from 16 lpm to 45 lpm. The insufflation pressure is user adjustable between 3 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure and low gas supply.
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