The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca/medelec Audiostar.
| Device ID | K863156 |
| 510k Number | K863156 |
| Device Name: | TECA/MEDELEC AUDIOSTAR |
| Classification | Stimulator, Auditory, 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 | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-18 |
| Decision Date | 1987-02-03 |