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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 K102988
Device Name ELECTRONIC BLOOD PRESURE MONITOR
Applicant
Shenzhen Pango Electronic Co., Ltd.
P.O.Box 237-023
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/06/2010
Decision Date 11/09/2010
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
Recalls CDRH Recalls
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