FDA 510(k) Application Details - K140138

Device Classification Name	More FDA Info for this Device
510(K) Number	K140138
Device Name	HEARTNAVIGATOR RELEASE 2.0
Applicant	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 3959 VAN DYKE ROAD, SUITE 245 LUTZ, FL 33558 US Other 510(k) Applications for this Company
Contact	MICHAEL DAYTON 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	01/22/2014
Decision Date	06/10/2014
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