FDA 510(k) Application Details - K161586

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K161586
Device Name	Nebulizer (Direct Patient Interface)
Applicant	SHENZHEN HOMED MEDICAL DEVICE CO., LTD NO.2 BUILDING, LONGGU INDUSTRIAL ZONE, LONGHUA TOWN Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Shengming Shi 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	06/08/2016
Decision Date	09/06/2017
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