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510(k) Data Aggregation

    K Number
    K010040
    Device Name
    SLEEVED FILTER
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2001-03-09

    (63 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

    Device Description

    Sleeved Filter, Sleeved HME/Filter.

    AI/ML Overview

    This is a marketing clearance letter for a medical device submitted to the FDA. It does not contain information about the acceptance criteria and study results for an AI/ML device. Therefore, I cannot extract the requested information from the provided text.

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