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 |