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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 K110603
Device Name HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
Applicant
I.E.M. GmbH
Cockerillstrasse 69
Stolberg,  DE 52222
Applicant Contact PETER KNIPP
Correspondent
I.E.M. GmbH
Cockerillstrasse 69
Stolberg,  DE 52222
Correspondent Contact PETER KNIPP
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/03/2011
Decision Date 12/16/2011
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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