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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 K112269
Device Name OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
Applicant
OSTAR MEDITECH CORP.
5f, # 46-4, Min-Chiuan Rd.
Shing-Tien Dist.
New Taipei City,  TW 231
Applicant Contact STEVEN CHANG
Correspondent
OSTAR MEDITECH CORP.
5f, # 46-4, Min-Chiuan Rd.
Shing-Tien Dist.
New Taipei City,  TW 231
Correspondent Contact STEVEN CHANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/08/2011
Decision Date 10/20/2011
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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