FDA 510(k) Application Details - K111803

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K111803
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	ESAOTE, S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 US Other 510(k) Applications for this Company
Contact	Allison Scott Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2011
Decision Date	07/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review