The following data is part of a premarket notification filed by Elucent Medical, Inc with the FDA for Envisio Navigation Sytem.
| Device ID | K183400 |
| 510k Number | K183400 |
| Device Name: | EnVisio Navigation Sytem |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Elucent Medical, Inc 7480 Flying Cloud Drive, Suite 110 Eden Prairie, MN 55344 |
| Contact | Debra Kridner |
| Correspondent | Debra Kridner Elucent Medical, Inc 7480 Flying Cloud Drive, Suite 110 Eden Prairie, MN 55344 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851674008065 | K183400 | 000 |
| 00851674008058 | K183400 | 000 |
| 00851674008041 | K183400 | 000 |
| 00851674008034 | K183400 | 000 |
| 00851674008225 | K183400 | 000 |
| 00851674008072 | K183400 | 000 |
| 10085167400822 | K183400 | 000 |
| 00851674008348 | K183400 | 000 |
| 00851674008232 | K183400 | 000 |