FDA 510(k) Application Details - K171828

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K171828
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Orantech Inc. Zone#A,4F,1st Bld, 7th Industrial Zone Yulv Community, GongMing, Guangming Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Yunxi Xiong Other 510(k) Applications for this Contact
Regulation Number	868.1400   More FDA Info for this Regulation Number
Classification Product Code	CCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2017
Decision Date	05/31/2018
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