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