510(k) K043091
K043091 is an FDA 510(k) premarket notification submitted by Image-Guided Neurologics, Inc. for the device "NAVIGUS NEXDRIVE, MODEL MI-3000". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Image-Guided Neurologics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2005
- Date Received
- November 9, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type