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510(k) Data Aggregation

    K Number
    K012485
    Device Name
    MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2001-10-09

    (68 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit.
    • A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care.
    • ventifator care.
      Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets it. The document is an FDA 510(k) clearance letter for a breathing circuit bacterial filter, which indicates that the device has been found substantially equivalent to predicate devices. It does not include specific performance data or a study description as requested.

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