FDA 510(k) Application Details - K001097

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K001097
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. MELBOURNE, FL 32935 US Other 510(k) Applications for this Company
Contact	DAVID M LEE 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	04/04/2000
Decision Date	01/18/2001
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