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 |