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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 K070086
Device Name SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
Applicant
Sensacare , Ltd.
2f, # 13, Lane 28, Sec. 1
Huanshan Rd.
Nei Hu, Taipei,  TW 114
Applicant Contact STEVEN CHANG
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/09/2007
Decision Date 05/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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