510(k) K070629
K070629 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions for the device "FLEX AND LOOP COIL SET 1.5 T". The FDA issued a decision of Substantially Equivalent on March 26, 2007. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2007
- Date Received
- March 7, 2007
- 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