FDA 510(k) Application Details - K140113

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K140113
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUTAIN ASH MID GLAMORGAN CF45 4ER GB Other 510(k) Applications for this Company
Contact	CHRIS WATKINS 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	01/15/2014
Decision Date	03/06/2014
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	Y
Expedited Review