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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 K043531
Device Name MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
Applicant
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Applicant Contact DANIEL TSENG
Correspondent
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Correspondent Contact DANIEL TSENG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/21/2004
Decision Date 04/21/2005
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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