Connect App For IHealth Next, IHealth React Native SDK, IHealth React Native Library SDK, IHealth Library SDK, IHealth Native SDK

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

Andon Health Co., Ltd

The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Connect App For Ihealth Next, Ihealth React Native Sdk, Ihealth React Native Library Sdk, Ihealth Library Sdk, Ihealth Native Sdk.

Pre-market Notification Details

Device IDK181541
510k NumberK181541
Device Name:Connect App For IHealth Next, IHealth React Native SDK, IHealth React Native Library SDK, IHealth Library SDK, IHealth Native SDK
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Andon Health Co., Ltd No.3 Jinping Street,Ya An Road, Nankai District Tianjin, P.R. China Tianjin,  CN 300190
ContactYi Liu
CorrespondentYi Liu
Andon Health Co., Ltd No.3 Jinping Street,Ya An Road, Nankai District Tianjin, P.R. China Tianjin,  CN 300190
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-11
Decision Date2019-04-16

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