FDA 510(k) Application Details - K200477

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K200477
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Quality Electrodynamics, LLC 6655 Beta Drive Suite 100 Mayfield Village, OH 44143 US Other 510(k) Applications for this Company
Contact	Eric Yeh Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2020
Decision Date	04/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review