FDA 510(k) Application Details - K191239

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K191239
Device Name	Meter, Peak Flow, Spirometry
Applicant	Guangzhou Homesun Medical Technology Co., Ltd Floor 7th, TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District Guangzhou 510250 CN Other 510(k) Applications for this Company
Contact	Jinqun Li Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2019
Decision Date	12/06/2019
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