Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250164
    Device Name
    Cassette Autoclave (ACA5)
    Date Cleared
    2025-08-14

    (205 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Ajax Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K202766
    Device Name
    EOS Air Cleaner
    Date Cleared
    2021-06-11

    (263 days)

    Product Code
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Ajax Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment. The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.
    Device Description
    EOS Air Cleaner employs an ultraviolet air purification technology that destroys bacteria and viruses in air in hospital, nursing homes, medical facilities, but not in specialized medical place such as operating rooms. EOS Air Cleaner is a free-standing device, which has a well-sealed metal box including a fine filter, motor, two UV-C lamps, and a HEPA filter. By sucking surrounding air into the device, EOS Air cleaner can suction the air into the device and filtering the air by fine filter with UV-C light radiation, then the purified air is expelled from the cabinet. The bacteriophage deposited onto the surface of EOA Air Cleaner's proprietary photocatalytic coated filter media will be killed after exposure to EOS Air Cleaner's UV-C light UV-C light in 255 nm which is commonly called germicidal kills any remaining bacteria and viruses, as the radiation penetrates the cell walls of bacteria and is absorbed by the organic structures within the bacterial and virus, causing them to decompose and the cell to die.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1