FDA 510(k) Application Details - K182362

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K182362
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Maxtec, LLC 2305 S 1070 W Salt Lake City, UT 84119 US Other 510(k) Applications for this Company
Contact	Tammy Lavery 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	08/30/2018
Decision Date	05/23/2019
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