The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Trajectory Guide Biopsy Kit, Models Bk-7000 And 8000.
| Device ID | K011971 |
| 510k Number | K011971 |
| Device Name: | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne, FL 32935 |
| Contact | David M Lee |
| Correspondent | David M Lee IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 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 | 2001-06-25 |
| Decision Date | 2001-08-03 |