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510(k) Data Aggregation

    K Number
    K252128
    Device Name
    Zener® (model ZEN-001-B1)
    Manufacturer
    UVX Inc.
    Date Cleared
    2025-09-15

    (70 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211194,K133800
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Zener® (model ZEN-001-B1) is an ultraviolet (UV) air purifying device intended for the reduction of bacteria in air in medical facilities. Zener has demonstrated the ability to reduce Klebsiella aerogenes in air by 4.73 net log-reduction at 50% ± 10% relative humidity and 23°C ± 3°C (73°F ± 5°F). Zener is non sterile.

    Device Description

    Zener is a ceiling-mounted and mains-powered ultraviolet (UV) air purifying device intended to reduce bacteria in air in medical facilities. The device functions autonomously by exposing air in the room to UV light.

    Physically, Zener measures 7" x 7" x 3.2", weighs 2.1 lbs, and mounts to ceilings using its backplate and an included ceiling bracket. The device's exterior surfaces are constructed with quartz glass, metal, and plastic. Device management is supported through a mobile and web application.

    AI/ML Overview

    N/A

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