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 |