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Airgle Corporation · Model AG930 · UDI-DI 00860013509958

FRA
1
510(k) clearances
12
Adverse events
0
Recalls
13
Facilities

Description

The Airgle Clean Room Air Purifier AG930 is a free-standing air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254 nm), intended for the inactivation of indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to be effective against MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure and operating conditions: Test Item(s): MS2Bacteriophage Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5): Model AG930: >4.0 log reduction / 120 minutes

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.