510(k) K994351
K994351 is an FDA 510(k) premarket notification submitted by Resonance Technology, Inc. for the device "M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 22, 2000. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 2000
- Date Received
- Dec 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)