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510(k) Data Aggregation

    K Number
    K984116
    Device Name
    HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
    Manufacturer
    ABATEMENT TECHNOLOGIES, INC.
    Date Cleared
    1999-06-24

    (219 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K072185
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "HEPA-CARE Air Cleaner." It is not a study report or a technical document detailing acceptance criteria and performance data. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

    The document primarily focuses on:

    • Confirming the FDA's review and determination of substantial equivalence for the device.
    • Stating the regulatory class of the device.
    • Outlining the general controls and regulations the device is subject to.
    • Providing contact information for regulatory inquiries.
    • Stating the intended use of the device, which is "for filtering out airborne particles from the air for medical purposes."

    In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and performance study details.

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