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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(With Arrhythmia Detection Or Alarms)
510(k) Number K152973
Device Name Dyna-Vision Telemonitoring System
Applicant
Techmedic Development International B.V.
Broeker Werf 6
Broek op Langedijk,  NL 1721 PC
Applicant Contact Rutger Brest van Kempen
Correspondent
Qserve Group US Inc.
P.O BOX 940
Charlestown,  NH  03603
Correspondent Contact Patsy J Trisler
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRG   DRT   DSI   FLL  
Date Received10/08/2015
Decision Date 04/29/2016
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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