510(k) K931112

MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI by Puritan Bennett Corp. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1993
Date Received
March 4, 1993
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