The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Syncor (r) Model S-801 Ecg Electrode.
| Device ID | K882216 |
| 510k Number | K882216 |
| Device Name: | SYNCOR (R) MODEL S-801 ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | Michael J Finley |
| Correspondent | Michael J Finley 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 | 1988-05-26 |
| Decision Date | 1988-07-20 |