The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Biologic System Bl 101.
| Device ID | K831047 |
| 510k Number | K831047 |
| Device Name: | BIOLOGIC SYSTEM BL 101 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | BIO-LOGIC SYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-05-13 |