The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Evomatic 8000/4000.
| Device ID | K843815 |
| 510k Number | K843815 |
| Device Name: | EVOMATIC 8000/4000 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | DANTEC ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-28 |
| Decision Date | 1985-05-31 |