510(k) K930265
K930265 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT". The FDA issued a decision of Substantially Equivalent on April 25, 1995. 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
- April 25, 1995
- Date Received
- January 19, 1993
- 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