The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Tracets 2000/electrodes.
| Device ID | K863674 |
| 510k Number | K863674 |
| Device Name: | TRACETS 2000/ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | Rolf, Ph.d. |
| Correspondent | Rolf, Ph.d. LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-19 |
| Decision Date | 1987-03-11 |