K243709 is an FDA 510(k) clearance for the NeuroEars-Anna™. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Neuroears, Inc. (Gangwon-Do, KR). The FDA issued a Cleared decision on August 25, 2025, 266 days after receiving the submission on December 2, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K243709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2024 |
| Decision Date | August 25, 2025 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | GWN - Nystagmograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1460 |