510(k) K920061

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

K920061 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 30, 1992. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. Abbott Laboratories has at least 10 other 510(k) clearances on record.

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