510(k) K862114

KHURI REGIONAL TISSUE PH MONITOR by Vascular Technology Incorporated — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1986
Date Received
June 3, 1986
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