TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM

Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Terumo Khuri Myocardial Ph Monitoring System.

Pre-market Notification Details

Device IDK020967
510k NumberK020967
Device Name:TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
ClassificationAnalyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
Applicant TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. Tustin,  CA  92780
ContactSteve Arick
CorrespondentSteve Arick
TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. Tustin,  CA  92780
Product CodeCBZ  
CFR Regulation Number868.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-25
Decision Date2002-06-20
Summary:summary

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