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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 K081159
Device Name HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
Applicant
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Applicant Contact PAUL AYLETT
Correspondent
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Correspondent Contact PAUL AYLETT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/14/2008
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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