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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 K190985
Device Name BAROnova Insufflation System, BAROnova Accessory Kit
BAROnova, Inc.
1551 Industrial Road
San Carlos,  CA  94070
Applicant Contact Lian Cunningham
BAROnova, Inc.
1551 Industrial Road
San Carlos,  CA  94070
Correspondent Contact Lian Cunningham
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received04/15/2019
Decision Date 05/14/2019
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No