510(k) K003575
K003575 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 2001. 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 17, 2001
- Date Received
- November 20, 2000
- 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