The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca/medelec Mistral.
| Device ID | K880593 |
| 510k Number | K880593 |
| Device Name: | TECA/MEDELEC MISTRAL |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Edward R Sirois |
| Correspondent | Edward R Sirois TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-04-06 |