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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 K063814
Device Name BP-200 PLUS
Applicant
Schiller AG
Altgasse 68
Baar,  CH 6341
Applicant Contact RETO KUETTEL
Correspondent
Schiller AG
Altgasse 68
Baar,  CH 6341
Correspondent Contact RETO KUETTEL
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DQA  
Date Received12/22/2006
Decision Date 03/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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