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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 K861504
Device Name MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
Applicant
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Applicant Contact DON ANDRESEN
Correspondent
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Correspondent Contact DON ANDRESEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/23/1986
Decision Date 08/25/1986
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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