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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 K062893
Device Name KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
Applicant
Shanghai Kodea Economic and Trade Development , Ltd.
Rome. 902, #15, Lane 28,
Qingjiang Rd.
Shanghai,  CN 200233
Applicant Contact ZHAO J YU
Correspondent
Shanghai Kodea Economic and Trade Development , Ltd.
Rome. 902, #15, Lane 28,
Qingjiang Rd.
Shanghai,  CN 200233
Correspondent Contact ZHAO J YU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/27/2006
Decision Date 02/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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