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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 K061760
Device Name ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
Applicant
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Applicant Contact DANNY WANG
Correspondent
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Correspondent Contact DANNY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/22/2006
Decision Date 08/14/2006
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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