FDA 510(k) Application Details - K143469

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K143469
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	TELEFLEX MEDICAL, INC. 2917 WECK DRIVE RESEARCH TRIANGLE, NC 27709 US Other 510(k) Applications for this Company
Contact	Brian Gall 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	12/05/2014
Decision Date	02/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review