FDA 510(k) Application Details - K192446

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K192446
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Beijing Kingst Commercial & Trade Co.,Ltd. 6th Floor of No.2-7,Road Beibinhe Xibianmen Beijing 100053 CN Other 510(k) Applications for this Company
Contact	Judong Gao 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	09/06/2019
Decision Date	05/21/2020
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