FDA 510(k) Application Details - K061901

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K061901
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	INO THERAPEUTICS 7601-B MURPHY DRIVE MIDDLETON, WI 53562 US Other 510(k) Applications for this Company
Contact	FREDERICK MONTGOMERY 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	07/05/2006
Decision Date	12/14/2006
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