510(k) K182737
K182737 is an FDA 510(k) premarket notification submitted by Nova Medical, Inc. for the device "3T 32 Channel Head Coil". The FDA issued a decision of Substantially Equivalent on Apr 12, 2019. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 12, 2019
- Date Received
- Sep 28, 2018
- 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)