510(k) K920061

HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM by Abbott Laboratories — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1992
Date Received
January 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1170
Review Panel
AN
Submission Type