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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K210768
Device Name Wrist Blood Pressure Monitor, Blood Pressure Monitor
Applicant
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
Nankai District
Tianjin,  CN 300190
Correspondent Contact Liu Yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/15/2021
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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