FDA 510(k) Application Details - K000653

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K000653
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	PULMONOX MEDICAL CORP. 5243-53 AVE. TOFIELD, ALBERTA T0B 4J0 CA Other 510(k) Applications for this Company
Contact	PAULA TOMAT 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	02/28/2000
Decision Date	08/04/2000
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