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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 K234041
Device Name Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
Applicant
Andon Health Co Ltd
No. 3 Jin Ping Street,Ya An Road
Nankai District
Tianjin,  CN 300190
Applicant Contact Yi Liu
Correspondent
Andon Health Co Ltd
No. 3 Jin Ping Street,Ya An Road
Nankai District
Tianjin,  CN 300190
Correspondent Contact Yi Liu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/21/2023
Decision Date 04/22/2024
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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