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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ph, Stomach
510(k) Number K102543
Device Name BRAVO PH MONITORING SYSTEM AND ACCESSORIES
Applicant
Given Imaging , Ltd.
P.O. Box 258
New Industrial Park
Yoqneam,  IL 20692
Applicant Contact Tim Thomas
Correspondent
Given Imaging , Ltd.
P.O. Box 258
New Industrial Park
Yoqneam,  IL 20692
Correspondent Contact Tim Thomas
Regulation Number876.1400
Classification Product Code
FFT  
Date Received09/03/2010
Decision Date 12/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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