FDA 510(k) Application Details - K003665

Device Classification Name	Apparatus, Nitric Oxide, Backup Delivery   More FDA Info for this Device
510(K) Number	K003665
Device Name	Apparatus, Nitric Oxide, Backup Delivery
Applicant	FADASIS MEDICAL, INC. 7601-B MURPHY DR. MIDDLETOWN, WI 53562 US Other 510(k) Applications for this Company
Contact	RAYMOND RIDDLE 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	11/28/2000
Decision Date	02/23/2001
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