FDA 510(k) Application Details - K984085

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K984085
Device Name	Nebulizer (Direct Patient Interface)
Applicant	AEROMAX TECHNOLOGIES, INC. 12020 S. WARNER/ELLIOT LOOP SUITE 124 PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	ALLAN M WACHTER 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	11/16/1998
Decision Date	08/05/1999
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