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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 K003732
Device Name BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
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 Received12/04/2000
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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