The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Teca Premiere.
| Device ID | K953732 |
| 510k Number | K953732 |
| Device Name: | TECA PREMIERE |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Contact | Jeff Hall |
| Correspondent | Jeff Hall MEDELEC LTD. MANOR WAY Old Woking, Surrey, DE Gu22 9ju |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1995-10-19 |