FDA 510(k) Application Details - K192633

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K192633
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Globalcare Medical Technology Co., Ltd. 7th Building, 39 Middle Industrial Main Road, European Industrial Zone Xiaolan Town, Zhongshan City 528415 CN Other 510(k) Applications for this Company
Contact	Janice Deng 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	09/23/2019
Decision Date	05/01/2020
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