K223047 is an FDA 510(k) clearance for the NeuroSwift Pro. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Neurobit Technologies Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 29, 2023, 273 days after receiving the submission on September 29, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K223047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | June 29, 2023 |
| Days to Decision | 273 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 |