FDA 510(k) Application Details - K091803

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K091803
Device Name	Nebulizer (Direct Patient Interface)
Applicant	NEXUS6, LTD. LEVEL 2, 109 COOK STREET AUCKLAND 1010 NZ Other 510(k) Applications for this Company
Contact	GARTH SUTHERLAND Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2009
Decision Date	10/09/2009
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	Y
Expedited Review