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510(k) Data Aggregation

    K Number
    K251872

    Validate with FDA (Live)

    Device Name
    Biomoneta Avata Rx
    Manufacturer
    Biomoneta Research Private Limited
    Date Cleared
    2025-11-14

    (149 days)

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

    The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only.

    The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes.

    Note: The designation "Rx" in the product name is part of the trade name and does not indicate prescription status.

    Performance was validated in controlled test chambers measuring 9.1 ft × 9.1 ft × 7 ft (bioaerosol) and 12 ft × 12.5 ft × 15 ft (particle reduction).

    Device Description

    Not Found

    AI/ML Overview

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