FDA 510(k) Application Details - K131686

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K131686
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	INO THERAPEUTICS/IKARIA 2902 DAIRY DRIVE MADISON, WI 53718 US Other 510(k) Applications for this Company
Contact	ROBERT BOVY Other 510(k) Applications for this Contact
Regulation Number	868.5165   More FDA Info for this Regulation Number
Classification Product Code	MRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2013
Decision Date	11/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review