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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 K853158
Device Name DIGITAL SPHYGMOMANOMETER MODEL 7620
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 Received07/30/1985
Decision Date 11/14/1985
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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