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510(k) Data Aggregation

    K Number
    K053149
    Device Name
    SPIRO-BALL
    Manufacturer
    Date Cleared
    2005-12-13

    (33 days)

    Product Code
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEVENTON, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spiro-Ball is a product for use in respiratory therapy and for adult people. It is intended for a single patient use, and it can be used both in the medical center and out of it (homecare therapies).
    Device Description
    SPIRO-BALL is a Volumetric Incentive Spirometer. It is a nonsterile device, which operates by inspiration, that lifts the piston placed inside the chamber.
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    K Number
    K040752
    Device Name
    DOSI-FUSER
    Manufacturer
    Date Cleared
    2004-04-07

    (14 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEVENTON, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.
    Device Description
    DOSI-FUSER is an Elastomeric Infusion Pump. It is a sterile and disposable infusion device, that operates by the action of compression of the elastomeric balloon that contains the liquid to instill. The liquid is supplied at a constant flow rate. DOSI-FUSER is a system for continuous and portable infusion of medication with a self-pressured container. It is a sterile and disposable device. The fluid contained in the balloon passes to the tube connected to the reservoir, goes through the filter (where particles in the fluid are retained and air bubbles are removed) and reaches the capillary. which fixes the flow rate that the patient will receive. The connector at the extreme of the tube must obviously be connected to a cannula. needle, etc. that contacts the blood vessel.
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    K Number
    K994074
    Device Name
    TRI-BALL
    Manufacturer
    Date Cleared
    2000-06-08

    (189 days)

    Product Code
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEVENTON, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.
    Device Description
    The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.
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