FDA 510(k) Application Details - K071506

Device Classification Name	System, Nuclear Magnetic Resonance Spectroscopic   More FDA Info for this Device
510(K) Number	K071506
Device Name	System, Nuclear Magnetic Resonance Spectroscopic
Applicant	HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK TWINSBURG, OH 44087 US Other 510(k) Applications for this Company
Contact	DOUG THISTLETHWAITE Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2007
Decision Date	06/28/2007
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