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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 K092558
Device Name WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
Applicant
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Applicant Contact MARTIN MA
Correspondent
Harvard Medical Devices , Ltd.
39 Chatham Rd. S.
Tsimshatsui, Kowloon,  HK
Correspondent Contact MARTIN MA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/20/2009
Decision Date 03/17/2010
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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