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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 K032927
Device Name FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
Applicant
Sein Electronics Co., Ltd.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
Sein Electronics Co., Ltd.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/22/2003
Decision Date 05/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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