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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 K850476
Device Name NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050
Applicant
Unisonic Products Corp.
Charles H. Helein
1255 Twenty-Third St.
Washington,  DC  20037
Applicant Contact & ALBERT
Correspondent
Unisonic Products Corp.
Charles H. Helein
1255 Twenty-Third St.
Washington,  DC  20037
Correspondent Contact & ALBERT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/29/1985
Decision Date 04/29/1985
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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