FDA 510(k) Application Details - K110635

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K110635
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	INO THERAPEUTICS LLC/DBA IKARIA 1060 Allendale Dr Port Allen, LA 70767 US Other 510(k) Applications for this Company
Contact	LARRY LEPLEY 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	03/04/2011
Decision Date	06/23/2011
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