510(k) K984167
K984167 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "SAGE 7". The FDA issued a decision of Substantially Equivalent on January 12, 1999. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. GE Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1999
- Date Received
- November 20, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Spectroscopic
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type