510(k) K130706
K130706 is an FDA 510(k) premarket notification submitted by Mr Instruments, Inc. for the device "DUOFLEX COIL SUITE (1.5T)". The FDA issued a decision of Substantially Equivalent on Jul 25, 2013. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Mr Instruments, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 25, 2013
- Date Received
- Mar 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)