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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 K012054
Device Name FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
Applicant
Sein Electronics Co., Ltd.
133-3, Pyungchon-Dong
Anyang-City, Kyunggi-Do,  KR
Applicant Contact WON. KY KIM
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MOLLY BETTGER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/02/2001
Decision Date 08/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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