K242726 is an FDA 510(k) clearance for the Synapsys VHIT. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Inventis S.R.L. (Padova, IT). The FDA issued a Cleared decision on January 3, 2025, 115 days after receiving the submission on September 10, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K242726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2024 |
| Decision Date | January 03, 2025 |
| Days to Decision | 115 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 |