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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling
510(k) Number K020967
Device Name TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
1311 VALENCIA AVE.
TUSTIN,  CA  92780
Applicant Contact STEVE ARICK
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
1311 VALENCIA AVE.
TUSTIN,  CA  92780
Correspondent Contact STEVE ARICK
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received03/25/2002
Decision Date 06/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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