The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Vitatrace.
| Device ID | K893425 |
| 510k Number | K893425 |
| Device Name: | VITATRACE |
| 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 | 1989-05-02 |
| Decision Date | 1989-07-14 |