510(k) K060967
K060967 is an FDA 510(k) premarket notification submitted by Stereotaxis, Inc. for the device "NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION". The FDA issued a decision of Substantially Equivalent on October 19, 2006. The device falls under product code NDQ (System, Catheter Or Guidewire, Steerable (Magnetic)), a Class II device regulated under 21 CFR 870.1290. Stereotaxis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2006
- Date Received
- April 7, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Catheter Or Guidewire, Steerable (Magnetic)
- Device Class
- Class II
- Regulation Number
- 870.1290
- Review Panel
- NE
- Submission Type