FDA 510(k) Application Details - K220533

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K220533
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Engineered Medical Systems Inc. 2055 Executive Dr Indianapolis, IN 46241 US Other 510(k) Applications for this Company
Contact	Tamara Lefevers 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	02/24/2022
Decision Date	11/16/2022
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