FDA 510(k) Application Details - K150472

Device Classification Name	More FDA Info for this Device
510(K) Number	K150472
Device Name	NxStage System One
Applicant	NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET LAWRENCE, MA 01843 US Other 510(k) Applications for this Company
Contact	Mary Lou Stroumbos Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ODN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2015
Decision Date	06/04/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review