510(k) K803014

SENSOMAT by Biochem International, Inc. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
November 28, 1980
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