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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
Viatom Technology Co., Ltd.
C607,Languang Park, No. 7 Xinxi Road
Hi-Tech Park( north)
Nanshan, Shenzhen,  CN 518057
Applicant Contact Zhou Saixin
Biologics Consulting Group, Inc.
400 N. Washington St. Suite 100
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2300
Classification Product Code
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