510(k) K183111
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2018
- Date Received
- November 8, 2018
- 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