FDA 510(k) Application Details - K961790

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling   More FDA Info for this Device
510(K) Number	K961790
Device Name	Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Applicant	OPTICAL SENSORS, INC. 7615 GOLDEN TRIANGLE DR., SUITE A EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DENISE A SSCHOTTLER 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	05/09/1996
Decision Date	04/09/1997
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