FDA 510(k) Application Details - K133360

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K133360
Device Name	Nebulizer (Direct Patient Interface)
Applicant	AEROGEN LTD IDA BUSINESS PARK, DANGAN GALWAY GALWAY IE Other 510(k) Applications for this Company
Contact	MARTIN CREHAN 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	11/01/2013
Decision Date	10/17/2014
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