The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Electrodes, Offset And Dx.
| Device ID | K781963 |
| 510k Number | K781963 |
| Device Name: | ELECTRODES, OFFSET AND DX |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-22 |
| Decision Date | 1978-12-19 |