The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for L.e.d. Goggles, Model 580-ledgog.
| Device ID | K852533 |
| 510k Number | K852533 |
| Device Name: | L.E.D. GOGGLES, MODEL 580-LEDGOG |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
| Contact | Gil Raviv |
| Correspondent | Gil Raviv BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-14 |
| Decision Date | 1985-12-12 |