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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 K014204
Device Name ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
Applicant
K-JUMP HEALTH CO., LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
K-JUMP HEALTH CO., LTD.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/21/2001
Decision Date 03/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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