FDA 510(k) Application Details - K062811

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K062811
Device Name	Nebulizer (Direct Patient Interface)
Applicant	LIFE OUTCOMES, INC. 3957 BLUE PINE CIRCLE HIGHLANDS RANCH, CO 80126-8077 US Other 510(k) Applications for this Company
Contact	CHARLES M HART 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	09/19/2006
Decision Date	12/20/2006
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