FDA 510(k) Application Details - K081691

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K081691
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	INO THERAPEUTICS LLC 2820 WALTON COMMONS WEST MADISON, WI 53718 US Other 510(k) Applications for this Company
Contact	DAVID TRUEBLOOD 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	06/17/2008
Decision Date	08/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review