The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Synkara.
| Device ID | K840445 |
| 510k Number | K840445 |
| Device Name: | SYNKARA |
| Classification | Electrode, Electrocardiograph |
| Applicant | LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
| Contact | Daniel R Vieths |
| Correspondent | Daniel R Vieths LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-30 |
| Decision Date | 1985-05-16 |