FDA 510(k) Application Details - K050104

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K050104
Device Name	Nebulizer (Direct Patient Interface)
Applicant	APEX MEDICAL CORP. NO. 9, MINSHENG STREET TUCHENG CITY, TAIPEI COUNTY 236 TW Other 510(k) Applications for this Company
Contact	ANAN CHANG 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	01/18/2005
Decision Date	02/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review