FDA 510(k) Application Details - K122857

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K122857
Device Name	Nebulizer (Direct Patient Interface)
Applicant	PEGASUS RESEARCH CORP. 3303 HARBO BLVD SUITE F3 COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	KENNETH MILLER 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	09/18/2012
Decision Date	11/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review