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    K Number
    K982127
    Device Name
    POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1998-06-23

    (6 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K964979
    Why did this record match?
    Device Name :

    POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.

    Device Description

    One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a respiratory filter and does not discuss acceptance criteria, device performance studies, or details about training and test sets as typically seen in AI/ML device submissions.

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