The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Eeg Lead Assembly.
| Device ID | K781494 |
| 510k Number | K781494 |
| Device Name: | EEG LEAD ASSEMBLY |
| Classification | Electrode, Cutaneous |
| Applicant | GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-10-31 |