Handheld VitalSigns Monitoring System

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

Visiomed Technology Co.,Ltd

The following data is part of a premarket notification filed by Visiomed Technology Co.,ltd with the FDA for Handheld Vitalsigns Monitoring System.

Pre-market Notification Details

Device IDK172965
510k NumberK172965
Device Name:Handheld VitalSigns Monitoring System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Visiomed Technology Co.,Ltd 2 Floor Of No.1 Building, Jia An Technological Industial Park, 67 District, Bao An, Shenzhen,,  CN 518000
ContactChen Xiaofeng
CorrespondentFiled Fu
Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen,  CN 518000
Product CodeMWI  
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-26
Decision Date2018-12-17
Summary:summary

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