FDA 510(k) Application Details - K123030

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K123030
Device Name	Nebulizer (Direct Patient Interface)
Applicant	DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C 3500 SOUTH DUPONT HIGHWAY DOVER, DE 19901 US Other 510(k) Applications for this Company
Contact	LEON LU 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	09/28/2012
Decision Date	12/19/2013
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