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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 K042418
Device Name KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Applicant
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
#31, Changjiang Rd.,
Nankai District
Tianjin,  CN 300193
Applicant Contact LIU YI
Correspondent
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
#31, Changjiang Rd.,
Nankai District
Tianjin,  CN 300193
Correspondent Contact LIU YI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/03/2004
Decision Date 03/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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