The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca/medelec 'concept' P420.
| Device ID | K884870 |
| 510k Number | K884870 |
| Device Name: | TECA/MEDELEC 'CONCEPT' P420 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Scott A Grillo |
| Correspondent | Scott A Grillo 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 | 1988-11-21 |
| Decision Date | 1989-02-23 |