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510(k) Data Aggregation

    K Number
    K014281
    Device Name
    GARD FILTER, COMBIGARD FILTE / HME
    Manufacturer
    MUNKTELL FILTER AB
    Date Cleared
    2002-06-26

    (181 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUNKTELL FILTER AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.
    Device Description
    The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.
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    K Number
    K014282
    Device Name
    BACSTOP FILTER,BACSTOP FILTER/HME
    Manufacturer
    MUNKTELL FILTER AB
    Date Cleared
    2002-06-26

    (181 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUNKTELL FILTER AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required. For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults). Single patient use. Duration of use up to 24 hours.
    Device Description
    The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
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