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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 K181541
Device Name Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
Applicant
Andon Health Co, Ltd.
#3 Jinping St., Ya An Rd., Nankai District, Tianjin
P.R. China
Tianjin,  CN 300190
Applicant Contact Yi Liu
Correspondent
Andon Health Co, Ltd.
#3 Jinping St., Ya An Rd., Nankai District, Tianjin
P.R. China
Tianjin,  CN 300190
Correspondent Contact Yi Liu
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/11/2018
Decision Date 04/16/2019
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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