FDA 510(k) Application Details - K112293

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K112293
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	TIME MEDICAL SYSTEMS INC G/F, BIO-INFORMATICS CENTRE NO.2, SCIENCE PARK WEST AVE SHATIN, N.T., HONG KONG CH CN Other 510(k) Applications for this Company
Contact	JOHN BABY 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	08/10/2011
Decision Date	09/30/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review