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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 K081590
Device Name YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
Applicant
Ya Horng Electronic Co., Ltd.
2f, # 13, Huanshan Rd.
Ln. 28, Sec 1
Nei Hu, Taipei,  TW 114
Applicant Contact STEVEN CHANG
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/06/2008
Decision Date 06/19/2008
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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