The following data is part of a premarket notification filed by Micromed S.p.a. with the FDA for Led Photic System.
| Device ID | K211974 |
| 510k Number | K211974 |
| Device Name: | LED PHOTIC System |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | Micromed S.p.A. Via Giotto 2 Mogliano Veneto, IT 31021 |
| Contact | Nicola Rizzo |
| Correspondent | Marina Ruotolo Micromed S.p.A. Via Giotto 2 Mogliano Veneto, IT 31021 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033928121207 | K211974 | 000 |
| 08033928121184 | K211974 | 000 |