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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 K032492
Device Name BLOOD PRESSURE MONITOR, MODEL KP-7000
Applicant
K-Jump Health Co., Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
K-Jump Health Co., Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/12/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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