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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 K150869
Device Name Checkme Pro Health Monitor
Applicant
Viatom Technology Co., Ltd.
c607,languang park, no. 7 xinxi road
hi-tech park( north)
nanshan, shenzhen,  CN 518057
Applicant Contact zhou saixin
Correspondent
Biologics Consulting Group, Inc.
400 n. washington st. suite 100
alexandria,  VA  22314
Correspodent Contact donna-bea tillman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/01/2015
Decision Date 12/10/2015
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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