FDA 510(k) Application Details - K071165

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling   More FDA Info for this Device
510(K) Number	K071165
Device Name	Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Applicant	ALERTIS MEDICAL AS 6470 RIVERVIEW TERRACE FRIDLEY, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE G BUNDY Other 510(k) Applications for this Contact
Regulation Number	868.1150   More FDA Info for this Regulation Number
Classification Product Code	CCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2007
Decision Date	11/07/2007
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