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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 K192023
Device Name Arm Blood Pressure Monitor
Applicant
Truly Instrument Limited
Site 2, Truly Industry Area
Shanwei,  CN 516600
Applicant Contact Su HaiSen
Correspondent
Truly (U.S.A), Inc.
2620 Concord Ave., Suite 106
Alhambra,  CA  91803
Correspondent Contact Max Wong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/29/2019
Decision Date 12/23/2019
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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