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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K170538
Device Name RVS-100 Vital Signs Monitor
Applicant
Rudolf Riester GmbH
P.O.B. 35, Bruckstraße 31
Jungingen,  DE 72417
Applicant Contact Christof Kleiner
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/23/2017
Decision Date 10/17/2017
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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