LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972064
    Device Name
    MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
    Manufacturer
    BIOLOGICAL CONTROLS, INC.
    Date Cleared
    1997-12-01

    (181 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV

    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

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a previously marketed device. It acknowledges the device's indications for use but does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer your request.

    The text is a regulatory approval document and not a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1