FDA 510(k) Application Details - K200836

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K200836
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen 518132 CN Other 510(k) Applications for this Company
Contact	Gary Wang 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	03/31/2020
Decision Date	07/22/2020
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