510(k) K072909
K072909 is an FDA 510(k) premarket notification submitted by Siemens AG Medical Solutions for the device "1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Siemens AG Medical Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2007
- Date Received
- October 12, 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