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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 K851664
Device Name MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
Applicant
Sharp Electronics Corp.
10 Sharp Plz.
P.O. Box 588
Paramus,  NJ  07652
Applicant Contact GLEN WEINBERG
Correspondent
Sharp Electronics Corp.
10 Sharp Plz.
P.O. Box 588
Paramus,  NJ  07652
Correspondent Contact GLEN WEINBERG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/23/1985
Decision Date 07/24/1985
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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