FDA 510(k) Application Details - K083578

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K083578
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 HOECHBERG 97204 DE Other 510(k) Applications for this Company
Contact	ZAHED SEDIGHIANI 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	12/03/2008
Decision Date	01/16/2009
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