K202766 is an FDA 510(k) clearance for the EOS Air Cleaner. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 11, 2021, 263 days after receiving the submission on September 21, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K202766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2020 |
| Decision Date | June 11, 2021 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRA — Purifier, Air, Ultraviolet, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6500 |