FDA 510(k) Application Details - K132946

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K132946
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Teleflex Medical, Inc. 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	Angela Bouse 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	09/19/2013
Decision Date	06/04/2014
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