The following data is part of a premarket notification filed by Lace Electronica S.r.l. with the FDA for Glaid Ocular Electrophysiology Device.
| Device ID | K043367 |
| 510k Number | K043367 |
| Device Name: | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | LACE ELECTRONICA S.R.L. 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Contact | Ian P Gordon |
| Correspondent | Ian P Gordon LACE ELECTRONICA S.R.L. 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-08 |
| Decision Date | 2005-11-17 |
| Summary: | summary |