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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 K921627
Device Name DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101
Applicant
Showa Engineering Co., Ltd.
C/O Elexis Corp.
70000 NW 46 St.
Miami,  FL  33166
Applicant Contact FRANK J BIANCO
Correspondent
Showa Engineering Co., Ltd.
C/O Elexis Corp.
70000 NW 46 St.
Miami,  FL  33166
Correspondent Contact FRANK J BIANCO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/06/1992
Decision Date 11/03/1992
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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