The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Electronystagmograph (eng Recorder).
| Device ID | K850180 |
| 510k Number | K850180 |
| Device Name: | ELECTRONYSTAGMOGRAPH (ENG RECORDER) |
| Classification | Nystagmograph |
| Applicant | BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
| Contact | Gabriel Raviv |
| Correspondent | Gabriel Raviv BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook, IL 60062 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-17 |
| Decision Date | 1985-07-22 |