The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Visual/audio Stimulator Model Cs-2.
| Device ID | K813009 |
| 510k Number | K813009 |
| Device Name: | TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | TECA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-27 |
| Decision Date | 1981-12-14 |