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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 K131569
Device Name PG-800A SERIES
Applicant
Shenzhen Pango Electronic Co., Ltd.
P.O.Box 237-023
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/30/2013
Decision Date 06/14/2013
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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