FDA 510(k) Application Details - K063813

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K063813
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	VENTLAB CORP. 155 BOYCE DRIVE MOCKSVILLE, NC 27028 US Other 510(k) Applications for this Company
Contact	JAMES A COCHIE 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	12/22/2006
Decision Date	03/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review