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510(k) Data Aggregation

    K Number
    K974682
    Device Name
    MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
    Manufacturer
    BIOLOGICAL CONTROLS, INC.
    Date Cleared
    1998-01-23

    (39 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP

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

    The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for several air purifier devices (Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier). It states that the devices are substantially equivalent to pre-amendment devices for the indication of filtering airborne particles from air for medical purposes.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information. The letter only grants market clearance based on substantial equivalence, implying that the manufacturer would have submitted data to demonstrate this equivalence in their 510(k) submission, but that data is not part of this letter.

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