FDA 510(k) Application Details - K020967

Device Classification Name	Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling   More FDA Info for this Device
510(K) Number	K020967
Device Name	Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Applicant	TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	STEVE ARICK Other 510(k) Applications for this Contact
Regulation Number	868.1170   More FDA Info for this Regulation Number
Classification Product Code	CBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2002
Decision Date	06/20/2002
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