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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 K190927
Device Name Oscillometric Blood Pressure Monitor
Applicant
Rudolf Riester GmbH
P.O. Box 35 Bruckstrasse 31
Jungingen,  DE D-72417
Applicant Contact Vivi Ding
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/09/2019
Decision Date 06/24/2019
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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