The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Teca. Millennium.
| Device ID | K965065 |
| 510k Number | K965065 |
| Device Name: | TECA. MILLENNIUM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Contact | Jeff Hall |
| Correspondent | Jeff Hall MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-18 |
| Decision Date | 1997-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043564 | K965065 | 000 |
| 00382830034425 | K965065 | 000 |
| 00382830034432 | K965065 | 000 |
| 00382830034449 | K965065 | 000 |
| 00382830035842 | K965065 | 000 |
| 00382830038751 | K965065 | 000 |
| 00382830038775 | K965065 | 000 |
| 00382830038799 | K965065 | 000 |
| 00382830038904 | K965065 | 000 |
| 00382830033374 | K965065 | 000 |
| 00382830033367 | K965065 | 000 |
| 00382830028691 | K965065 | 000 |
| 00382830028998 | K965065 | 000 |
| 00382830029001 | K965065 | 000 |
| 00382830029322 | K965065 | 000 |
| 00382830029384 | K965065 | 000 |
| 00382830031431 | K965065 | 000 |
| 00382830032650 | K965065 | 000 |
| 00382830032674 | K965065 | 000 |
| 00382830039024 | K965065 | 000 |
| 00382830039055 | K965065 | 000 |
| 00382830039543 | K965065 | 000 |
| 00382830041591 | K965065 | 000 |
| 00382830043496 | K965065 | 000 |
| 00382830043502 | K965065 | 000 |
| 00382830043519 | K965065 | 000 |
| 00382830043526 | K965065 | 000 |
| 00382830043540 | K965065 | 000 |
| 00382830043557 | K965065 | 000 |
| 00382830039536 | K965065 | 000 |
| 00382830039529 | K965065 | 000 |
| 00382830039079 | K965065 | 000 |
| 00382830039093 | K965065 | 000 |
| 00382830039376 | K965065 | 000 |
| 00382830039475 | K965065 | 000 |
| 00382830039482 | K965065 | 000 |
| 00382830039499 | K965065 | 000 |
| 00382830039505 | K965065 | 000 |
| 00382830039512 | K965065 | 000 |
| 00382830019095 | K965065 | 000 |