510(k) K091047
K091047 is an FDA 510(k) premarket notification submitted by Lmt Medical Systems GmbH for the device "NEONATE ARRAY COILS". The FDA issued a decision of Substantially Equivalent on Aug 18, 2010. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Lmt Medical Systems GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2010
- Date Received
- Apr 13, 2009
- 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)