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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 K141615
Device Name ENDOPHYS BLOOD PRESSURE MONITOR
Applicant
ENDOPHYS, INC.
755 N. MATHILDA, AVE.
SUITE 100
SUNNYVALE,  CA  94085
Applicant Contact RONALD S WARREN
Correspondent
ENDOPHYS, INC.
755 N. MATHILDA, AVE.
SUITE 100
SUNNYVALE,  CA  94085
Correspondent Contact RONALD S WARREN
Regulation Number870.1110
Classification Product Code
DSK  
Date Received06/16/2014
Decision Date 01/07/2015
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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