510(k) K083578
K083578 is an FDA 510(k) premarket notification submitted by Noras Mri Products GmbH for the device "NORAS CPC MULTIFUNCTIONAL COIL". The FDA issued a decision of Substantially Equivalent on January 16, 2009. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Noras Mri Products GmbH has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2009
- Date Received
- December 3, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type