K230502 is an FDA 510(k) clearance for the Ear Pressure Relief Device(Model:ER813B). This device is classified as a Device, Inflation, Middle Ear.
Submitted by Ningbo Albert Novosino Co., Ltd. (Yuyao, CN). The FDA issued a Cleared decision on June 9, 2023, 105 days after receiving the submission on February 24, 2023.
This device falls under the Ear, Nose, Throat FDA review panel.
| 510(k) Number | K230502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2023 |
| Decision Date | June 09, 2023 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MJV - Device, Inflation, Middle Ear |
| Device Class | - |