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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 K112647
Device Name BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
Applicant
Wistron Corporation
3f, 5f, No 127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact TELING HSU
Correspondent
Wistron Corporation
3f, 5f, No 127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact TELING HSU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/12/2011
Decision Date 11/22/2011
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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