Submission Details
| 510(k) Number | K230502 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Ear Pressure Relief Device(Model:ER813B)
Jun 2023
Decision
105d
Days
—
Risk
About This 510(k) Submission
K230502 is an FDA 510(k) clearance for the Ear Pressure Relief Device(Model:ER813B), 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 review panel.
Device Classification
| Product Code | MJV — Device, Inflation, Middle Ear |
| Device Class | — |
Manufacturer
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