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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 K863672
Device Name MODEL (MB-700) BLOOD PRESSURE MONITOR
Applicant
Sharp Electronics Corp.
P.O.Box 650
Mahwah,  NJ  07430
Applicant Contact TONY BERNARDO
Correspondent
Sharp Electronics Corp.
P.O.Box 650
Mahwah,  NJ  07430
Correspondent Contact TONY BERNARDO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/03/1986
Decision Date 11/18/1986
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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