FDA 510(k) Application Details - K151000

Device Classification Name	More FDA Info for this Device
510(K) Number	K151000
Device Name	O-Arm O2 Imaging System
Applicant	MEDTRONIC INC. 300 FOSTER STREET LITTLETON, MA 01460 US Other 510(k) Applications for this Company
Contact	RISHI SINHA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2015
Decision Date	08/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review