FDA 510(k) Application Details - K173147

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K173147
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Revolutionary Medical Devices, Inc. 4090 E. Bujia Primera Tucson, AZ 85718 US Other 510(k) Applications for this Company
Contact	David M. Kane 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	09/29/2017
Decision Date	06/20/2018
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