FDA 510(k) Application Details - K112002

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K112002
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD SHANGHAI 201107 CN Other 510(k) Applications for this Company
Contact	MEIJUAN CHEN 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	07/13/2011
Decision Date	11/18/2011
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