510(k) K080820
K080820 is an FDA 510(k) premarket notification submitted by Mr Instruments, Inc. for the device "TEM 3002G- HN DUAL TUNE HEAD COIL". The FDA issued a decision of Substantially Equivalent on Apr 2, 2008. 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
- Apr 2, 2008
- Date Received
- Mar 24, 2008
- 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)