The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Led Stimulator Ls-05.
| Device ID | K834442 |
| 510k Number | K834442 |
| Device Name: | LED STIMULATOR LS-05 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | TECA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-16 |
| Decision Date | 1984-08-08 |