FDA 510(k) Application Details - K133105

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K133105
Device Name	Nebulizer (Direct Patient Interface)
Applicant	DIGIO2 INTERNATIONAL CO., LTD NO,45, MINSHENG RD, DANSHUI TOWN NEW TAIPEI CITY 251 TW Other 510(k) Applications for this Company
Contact	MICHAEL LEE 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	09/30/2013
Decision Date	06/24/2014
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