K242198 is an FDA 510(k) clearance for the ICS Dizcovery (1091). This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Natus Medical Denmark Aps (Taastrup, DK). The FDA issued a Cleared decision on February 14, 2025, 203 days after receiving the submission on July 26, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K242198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2024 |
| Decision Date | February 14, 2025 |
| Days to Decision | 203 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 |