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510(k) Data Aggregation

    K Number
    K242102
    Device Name
    CerroZone Mini
    Manufacturer
    CerroZone LLC
    Date Cleared
    2024-11-19

    (124 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    CerroZone LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CerroZone Mini is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
    Device Description
    The CerroZone Mini is a medical recirculating air cleaner that uses multiple inactivation processes, including use of reactive oxidizing species (ozone) and ultraviolet radiation, to inactivate bacteria and viruses in the CerroZone Mini may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mini's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 110 cubic feet of air per minute (CFM), or 2.00 air changes per hour (ACH) in a standard 5,600 cubic foot room. The process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction, or 99.99% reduction, of airborne particles in a standard 579 cubic foot room is achieved in 45 minutes or less.
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    K Number
    K220298
    Device Name
    CerroZone Mobile
    Manufacturer
    CerroZone
    Date Cleared
    2022-07-01

    (149 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    CerroZone

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
    Device Description
    The CerroZone Mobile is a medical recirculating air cleaner that uses multiple inactivation processes consisting of reactive oxidizing species (ozone) and ultraviolet radiation to inactivate bacteria and viruses in the air. The CerroZone Mobile may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mobile's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 220 cubic feet of air per minute (CFM), or 2.36 air changes per hour (ACH) in a standard 5,600 cu. Ft room. This process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction of airborne particles in a standard 579 cu. Ft room is achieved in 30 minutes or less. A 5.67 LOG, or 99.9998%, reduction is achieved in 45 minutes or less.
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