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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
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