510(k) K994316
K994316 is an FDA 510(k) premarket notification submitted by Siemens Medical Corp. for the device "MAGNETOM OPEN VIVA WITH PERMANENT MAGNET". The FDA issued a decision of Substantially Equivalent on January 14, 2000. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2000
- Date Received
- December 22, 1999
- Clearance Type
- Special
- 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