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510(k) Data Aggregation

    K Number
    K032322
    Device Name
    CLEAR-THERM MICRO HME, MODEL 1441
    Manufacturer
    INTERSURGICAL, INC.
    Date Cleared
    2004-05-13

    (290 days)

    Product Code
    CAH
    Regulation Number
    868.5260
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    Matched: '868.5620'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the patient and equipment and is designed to reduce bacterial/viral contamination between patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
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    K Number
    K033008
    Device Name
    AIR SAFETY HEPA AND NON-HEPA FILTERS
    Manufacturer
    AIR SAFETY LTD
    Date Cleared
    2004-05-13

    (230 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Search-Everything :

    Matched: '868.5620'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anesthesia / Respiratory Filters For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired. Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
    Device Description
    The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.
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