The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Sapphire Series 1p, 1l, 2l, And 2me.
| Device ID | K903731 |
| 510k Number | K903731 |
| Device Name: | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Arthur Blumenfeld |
| Correspondent | Arthur Blumenfeld TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1991-02-04 |