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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 K894062
Device Name ELECTRONIC BLOOD PRESSURE MONITORS
Applicant
Hanson Scale Co.
Division Sunbeam Corp.
P.O. Box 38
Shubuta,  MS  39360
Applicant Contact RAY
Correspondent
Hanson Scale Co.
Division Sunbeam Corp.
P.O. Box 38
Shubuta,  MS  39360
Correspondent Contact RAY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/08/1989
Decision Date 08/24/1989
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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