The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Ii Mr.
| Device ID | K012719 |
| 510k Number | K012719 |
| Device Name: | NAVIGUS II MR |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2001-10-22 |