The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Evoked Potential Sys.
| Device ID | K842543 |
| 510k Number | K842543 |
| Device Name: | EVOKED POTENTIAL SYS |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | BIO-LOGIC SYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Scott Mann |
| Correspondent | Scott Mann BIO-LOGIC SYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-11-29 |