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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
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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