FDA 510(k) Application Details - K151653

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K151653
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	SHENZHEN RFTECH CO., LTD. 2-F, BLDG 4, JUHUI INDUSTRIAL PARK, TIANLIAO, GUANGMING, SHENZHEN 51832 CN Other 510(k) Applications for this Company
Contact	KE XI 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	06/18/2015
Decision Date	08/07/2015
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