510(k) K080515
K080515 is an FDA 510(k) premarket notification submitted by Nordicneurolab for the device "FMRI HARDWARE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 16, 2008. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Nordicneurolab has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2008
- Date Received
- February 25, 2008
- 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