K221471 is an FDA 510(k) clearance for the E3 and Profile. This device is classified as a Stimulator, Photic, Evoked Response (Class II - Special Controls, product code GWE).
Submitted by Diagnosys, LLC (Lowell, US). The FDA issued a Cleared decision on November 22, 2022, 186 days after receiving the submission on May 20, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 882.1890.
| 510(k) Number | K221471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | November 22, 2022 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | GWE - Stimulator, Photic, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1890 |