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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K123047
Device Name BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
Applicant
Bracco Diagnostic, Inc.
107 College Rd.
Princeton,  NJ  08540
Applicant Contact TRACEY ALEXANDER
Correspondent
Bracco Diagnostic, Inc.
107 College Rd.
Princeton,  NJ  08540
Correspondent Contact TRACEY ALEXANDER
Regulation Number876.1500
Classification Product Code
FCX  
Subsequent Product Code
FDS  
Date Received09/28/2012
Decision Date 08/06/2013
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
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