The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Quikset Dx Diag. Elect-.
| Device ID | K834445 |
| 510k Number | K834445 |
| Device Name: | MEDI-TRACE QUIKSET DX DIAG. ELECT- |
| 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 | 1983-12-16 |
| Decision Date | 1984-04-01 |