FDA 510(k) Application Details - K021175

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K021175
Device Name	Nebulizer (Direct Patient Interface)
Applicant	AEROGEN, INC. 1310 Orleans Dr. Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	TRACI V. A EDWARDS 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	04/12/2002
Decision Date	05/15/2002
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