NAVIGUS NEXDRIVE, MODEL MI-3000
FDA 510(k) clearance K043091 · decided 2005-02-07
Clearance details
- K-number
- K043091
- Device name
- NAVIGUS NEXDRIVE, MODEL MI-3000
- Applicant
- Image-Guided Neurologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-09
- Decision date
- 2005-02-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Melbourne, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-10 recall (Z-0849-2008) | Medtronic Image Guided Neurologics, Inc. | 2008-02-07 |