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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 K170966
Device Name TONOPORT VI
Applicant
Par Medizintechnik GmbH & Co. KG
Sachsendamm 6
Berlin,  DE 10829
Applicant Contact Buelent Tek
Correspondent
Par Medizintechnik GmbH & Co. KG
Sachsendamm 6
Berlin,  DE 10829
Correspondent Contact Thomas Fischer
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/31/2017
Decision Date 06/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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