K200321 is an FDA 510(k) clearance for the Novaerus NV1050. This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Novaerus Us, Inc. (Stamford, US). The FDA issued a Cleared decision on December 28, 2020, 322 days after receiving the submission on February 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K200321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2020 |
| Decision Date | December 28, 2020 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRF - Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |