The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 5' Offset Electrode.
| Device ID | K822750 |
| 510k Number | K822750 |
| Device Name: | MEDI-TRACE 5' OFFSET ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | GRAPHIC CONTROLS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-13 |
| Decision Date | 1982-11-01 |