The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Ms-20 Mystro Electrophysiological.
| Device ID | K842886 |
| 510k Number | K842886 |
| Device Name: | TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL |
| Classification | Nystagmograph |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Edward Sirois |
| Correspondent | Edward Sirois TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-12-12 |