The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Evolution.
| Device ID | K924127 |
| 510k Number | K924127 |
| Device Name: | DANTEC EVOLUTION |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1993-03-10 |