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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 K843390
Device Name COPAL DIGITAL SPHYGMOMANOMETER UA-535
Applicant
Takeda Medical, Inc.
17945Skypark Cir.
Irvine,  CA  92714
Applicant Contact MICHAEL OHSAWA
Correspondent
Takeda Medical, Inc.
17945Skypark Cir.
Irvine,  CA  92714
Correspondent Contact MICHAEL OHSAWA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/29/1984
Decision Date 05/15/1985
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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