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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 K951977
Device Name DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
Applicant
Integrated Display Technology, Ltd.
9f Kaiser Estate
41 Yue St.
Hunghom, Kowloon,  HK
Applicant Contact LEO NH
Correspondent
Integrated Display Technology, Ltd.
9f Kaiser Estate
41 Yue St.
Hunghom, Kowloon,  HK
Correspondent Contact LEO NH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/27/1995
Decision Date 10/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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