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510(k) K803260

SENSOMAT MUSCLE/TISSUE PH by Biochem International, Inc. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
December 24, 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

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  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
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