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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 K091434
Device Name TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
Applicant
Truly Instrument Co., Ltd.
Truly Industrical Area
Shanwei Shi, Guang Dong,  CN 516600
Applicant Contact YANGJIAN HAO
Correspondent
Truly Instrument Co., Ltd.
Truly Industrical Area
Shanwei Shi, Guang Dong,  CN 516600
Correspondent Contact YANGJIAN HAO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/13/2009
Decision Date 09/04/2009
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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