The following data is part of a premarket notification filed by Bluezone Products, Inc. with the FDA for Bluezone Model Rx-450 Air Purifier.
| Device ID | K212824 |
| 510k Number | K212824 |
| Device Name: | Bluezone Model RX-450 Air Purifier |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | Bluezone Products, Inc. 225 Wildwood Avenue Woburn, MA 01801 |
| Contact | Karen Benedek |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultant, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-02-17 |