510(k) K193140
K193140 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics, LLC for the device "Flex Body SPEEDER". The FDA issued a decision of Substantially Equivalent on January 3, 2020. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2020
- Date Received
- November 13, 2019
- 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