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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K160945
Device Name Endophys Blood Pressure Monitor
Applicant
Endophys Holdings, LLC
1601 Elm St.
Dallas,  TX  75201
Applicant Contact Rebecca K. Pine
Correspondent
Endophys Holdings, LLC
1601 Elm St.
Dallas,  TX  75201
Correspondent Contact Rebecca K. Pine
Regulation Number870.1110
Classification Product Code
DSK  
Date Received04/05/2016
Decision Date 09/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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