FDA 510(k) Application Details - K150591

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K150591
Device Name	Nebulizer (Direct Patient Interface)
Applicant	BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD NEW TAIPEI CITY 24888 TW Other 510(k) Applications for this Company
Contact	WINNIE CHUNG 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	03/09/2015
Decision Date	06/30/2015
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