510(k) K080120
K080120 is an FDA 510(k) premarket notification submitted by Philips Medical Systems MR Finland for the device "HFO SHOULDER COIL". The FDA issued a decision of Substantially Equivalent on Mar 10, 2008. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems MR Finland has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 10, 2008
- Date Received
- Jan 17, 2008
- 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
- 510(k)