The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Unibody Fiducial Marker System, Model Fm-4000.
| Device ID | K033619 |
| 510k Number | K033619 |
| Device Name: | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 |
| 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 | 2003-11-18 |
| Decision Date | 2004-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994747840 | K033619 | 000 |
| 20613994747833 | K033619 | 000 |
| 20613994747826 | K033619 | 000 |
| 10873263007751 | K033619 | 000 |
| 10873263007744 | K033619 | 000 |
| 10873263007737 | K033619 | 000 |
| 00873263008577 | K033619 | 000 |
| 00873263008560 | K033619 | 000 |
| 00873263008553 | K033619 | 000 |