510(k) K113365
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2012
- Date Received
- November 15, 2011
- Clearance Type
- Traditional
- 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