K212824 is an FDA 510(k) clearance for the Bluezone Model RX-450 Air Purifier. This device is classified as a Purifier, Air, Ultraviolet, Medical (Class II - Special Controls, product code FRA).
Submitted by Bluezone Products, Inc. (Woburn, US). The FDA issued a Cleared decision on February 17, 2022, 167 days after receiving the submission on September 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6500.
| 510(k) Number | K212824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2021 |
| Decision Date | February 17, 2022 |
| Days to Decision | 167 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 |