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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K153600
Device Name Consult Station TS
Applicant
H4D Sas
92 Ave. Kleber
Paris,  FR
Applicant Contact MARTA RIVAS
Correspondent
Voisin Consulting Life Sciences
222 Third St.
Suite 3121
Cambridge,  MA  02142
Correspondent Contact ESIN YESILALAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/16/2015
Decision Date 03/17/2017
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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