FDA 510(k) Application Details - K052663

Device Classification Name	Apparatus, Nitric Oxide, Backup Delivery   More FDA Info for this Device
510(K) Number	K052663
Device Name	Apparatus, Nitric Oxide, Backup 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	MRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2005
Decision Date	11/04/2005
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