K211974 is an FDA 510(k) clearance for the LED PHOTIC System. This device is classified as a Stimulator, Photic, Evoked Response (Class II - Special Controls, product code GWE).
Submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on September 23, 2021, 90 days after receiving the submission on June 25, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1890.
| 510(k) Number | K211974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2021 |
| Decision Date | September 23, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWE - Stimulator, Photic, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1890 |