FDA 510(k) Application Details - K011416

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K011416
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	MILLENNIUM MAGNETIC IMAGING, INC. 210 LORNA SQUARE, PMB 192 HOOVER, AL 35216 US Other 510(k) Applications for this Company
Contact	DONALD H MARKS 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	05/08/2001
Decision Date	08/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review