K203754 is an FDA 510(k) clearance for the Eustachi Ear Pressure Relief Device. This device is classified as a Device, Inflation, Middle Ear.
Submitted by Exercore, LLC (Shakopee, US). The FDA issued a Cleared decision on February 19, 2021, 58 days after receiving the submission on December 23, 2020.
This device falls under the Ear, Nose, Throat FDA review panel.
| 510(k) Number | K203754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | February 19, 2021 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MJV - Device, Inflation, Middle Ear |
| Device Class | - |