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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 K050083
Device Name BLOOD-PRESSURE METER, BPW120
Applicant
Idt Technology Limited
Block C, 9/F., Kaiser Estate,
Phase 1, 41 Man Yue St.
Kowloon,  HK
Applicant Contact LEON LEONG
Correspondent
Idt Technology Limited
Block C, 9/F., Kaiser Estate,
Phase 1, 41 Man Yue St.
Kowloon,  HK
Correspondent Contact LEON LEONG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/13/2005
Decision Date 04/08/2005
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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