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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flowmeter, blood, cardiovascular
510(k) Number K201114
Device Name Bidop 7
Applicant
Koven Technology, Inc.
477 N. Lindbergh Blvd., Ste.220
St. Louis,  MO  63141
Applicant Contact Heather Bell
Correspondent
Delphi Consulting Group
11874 South Evelyn Circle
Houston,  TX  77071
Correspondent Contact Harvey Knauss
Regulation Number870.2100
Classification Product Code
DPW  
Date Received04/27/2020
Decision Date 01/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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