The following data is part of a premarket notification filed by Teca, Inc. with the FDA for #st10 Progr. Evoked Response Stimulator.
| Device ID | K822744 |
| 510k Number | K822744 |
| Device Name: | #ST10 PROGR. EVOKED RESPONSE STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | TECA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-10 |
| Decision Date | 1982-11-03 |