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 |