The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Tracet Ag 4000.
| Device ID | K904512 |
| 510k Number | K904512 |
| Device Name: | TRACET AG 4000 |
| Classification | Electrode, Electrocardiograph |
| Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | David Montecalvo |
| Correspondent | David Montecalvo 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 | 1990-10-02 |
| Decision Date | 1991-01-31 |