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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 K012035
Device Name BRAUN PRECISION SENSOR PRO, MODEL BP 2590
Applicant
Braun GmbH
6183 Paseo Del Morte
Suite 150
Carlsbad,  CA  92009
Applicant Contact FRED SCHLADOR
Correspondent
Braun GmbH
6183 Paseo Del Morte
Suite 150
Carlsbad,  CA  92009
Correspondent Contact FRED SCHLADOR
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/29/2001
Decision Date 07/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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