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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 K852564
Device Name COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
Applicant
Takeda Medical, Inc.
17945 Skypark Cir.
Irvine,  CA  92714
Applicant Contact MICHAEL OHSAWA
Correspondent
Takeda Medical, Inc.
17945 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact MICHAEL OHSAWA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/20/1985
Decision Date 08/19/1985
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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