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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 K113085
Device Name TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
Applicant
TRULY INSTRUMENT CO., LTD.
2620 CONCORD AVENUE
SUITE 106
ALHAMBRA,  CA  91803
Applicant Contact MAX WONG
Correspondent
TRULY INSTRUMENT CO., LTD.
2620 CONCORD AVENUE
SUITE 106
ALHAMBRA,  CA  91803
Correspondent Contact MAX WONG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/18/2011
Decision Date 01/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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