FDA 510(k) Application Details - K172365

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K172365
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Pom Medical, LLC 1230 Madera Rd., Suite 5, Box 101 Simi Valley, CA 92065 US Other 510(k) Applications for this Company
Contact	Jeff Voss 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	08/04/2017
Decision Date	04/19/2018
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