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510(k) Data Aggregation

    K Number
    K232642
    Device Name
    AirKEE T900
    Manufacturer
    HealKEE Medical Pte Ltd
    Date Cleared
    2024-05-23

    (267 days)

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

    HealKEE Medical Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions: Test Item | Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test -----------|------------------------------------------------------------------------------------------------------------------ Bacteria | Staphylococcus albus Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed Bacteria | Escherichia coli Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed Mold | Penicillium rocqueforti Log 4 (99.99%)/60 minutes @ high fan speed Mold | Aspergillus Niger Log 4 (99.99%)/120 minutes @ low fan speed Virus | Influenza A virus, H1N1 Log 4 (99.99%)/60 minutes @ high fan speed Virus | Influenza A virus, H3N2 Log 4 (99.99%)/120 minutes @ low fan speed
    Device Description
    AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine. AirKEE T900's main components consist of: Multi-stage air treatment - a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter - UV lamps that generate UV-C irradiation to eliminate microorganisms о - o a motor/impeller to move air through the filtration system System control - o an electronic control system to power and control the device - a touch panel interface to indicate the working status of the device and consumables O AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine. The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
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    K Number
    K232933
    Device Name
    AirKEE P900
    Manufacturer
    HealKEE Medical Pte Ltd
    Date Cleared
    2024-05-16

    (239 days)

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

    HealKEE Medical Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE P900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions: Test Item | Avg. max Log Reduction/Entrainment Time (min) (in a 20m3 chamber) ---|--- Bacteria Staphylococcus aureus | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Escherichia coli | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Mold<br>Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Virus<br>Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Virus<br>Influenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed
    Device Description
    AirKEE P900 is a mobile multi-function medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE P900 is controlled via a touchscreen control panel on the machine. AirKEE P900's main components consist of: Multi-stage air treatment - a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter - UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o - a motor/impeller to move air through the filtration system o System control - o a touch panel interface to indicate the working status of the device and consumables AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner. The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
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