Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Viatom Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Viatom Technology Co., Ltd. with the FDA for Blood Pressure Monitor.

Pre-market Notification Details

Device IDK193348
510k NumberK193348
Device Name:Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Viatom Technology Co., Ltd. 4E, Building 3, Tingwei Industrial Park, No.6, Liufang Road Block 67, Xin'an Street, Baoan District Shenzhen,  CN 518101
ContactZhou Saixin
CorrespondentLucy Yan
Shenzhen Viatom Technology Co., Ltd. 4205-4210#, Shenzhen International Chamber Of Commerce Tower 168#, Fuhua 3 Road, Futian District Shenzhen,  CN 518048
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-03
Decision Date2020-06-25

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