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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K211068
Device Name PrevisEA Device
Applicant
Entac Medical, Inc.
680 Oakleaf Office Ln., Suite 201
Memphis,  TN  38117
Applicant Contact Buddy Lyons
Correspondent
Target Health, LLC
261 Madison Ave., 24th Floor
New York,  NY  10016
Correspondent Contact Adam Harris
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/12/2021
Decision Date 08/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03505476
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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