FDA 510(k) Application Details - K170820

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K170820
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	CMI Health Inc. 5975 Shiloh Road, Suite 114 Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Jiacheng Ren 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	03/20/2017
Decision Date	07/18/2018
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