The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Lectec Non-invasive Pacing Electrode.
| Device ID | K872012 |
| 510k Number | K872012 |
| Device Name: | LECTEC NON-INVASIVE PACING ELECTRODE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| 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 | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-06-29 |