The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Nicolet Electromagnetic Navigation System.
| Device ID | K013419 |
| 510k Number | K013419 |
| Device Name: | NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Contact | David W Wagner |
| Correspondent | David W Wagner NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-12-20 |