K221892 is an FDA 510(k) clearance for the VISIONAIR. This device is classified as a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II - Special Controls, product code BXQ).
Submitted by Pacificmd Biotech, LLC (Henderson, US). The FDA issued a Cleared decision on October 5, 2022, 98 days after receiving the submission on June 29, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 868.1800.
| 510(k) Number | K221892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2022 |
| Decision Date | October 05, 2022 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | BXQ — Rhinoanemometer (measurement Of Nasal Decongestion) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1800 |