510(k) K171515
K171515 is an FDA 510(k) premarket notification submitted by Lmt Medical Systems GmbH for the device "NHAC 16". The FDA issued a decision of Substantially Equivalent on Jul 26, 2017. 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
- Jul 26, 2017
- Date Received
- May 24, 2017
- Clearance Type
- Special
- 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)