Checkme Pro Health Monitor

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Viatom Technology Co., Ltd.

The following data is part of a premarket notification filed by Viatom Technology Co., Ltd. with the FDA for Checkme Pro Health Monitor.

Pre-market Notification Details

Device IDK150869
510k NumberK150869
Device Name:Checkme Pro Health Monitor
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Viatom Technology Co., Ltd. C607,Languang Park, No. 7 Xinxi Road Hi-Tech Park( North) Nanshan, Shenzhen,  CN 518057
ContactZhou Saixin
CorrespondentDonna-bea Tillman
Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria,  VA  22314
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-01
Decision Date2015-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06934440100713 K150869 000
06934440100010 K150869 000

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