510(k) K912428

PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT by Puritan Bennett Corp. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 31, 1991
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