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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K060756
Device Name MEDLOG, MODEL 1-0-10
Original Applicant
BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH
martinistrasse 52
pavillon 41a (uke)
hamburg,  GM d-20251
Original Contact angelika m berger
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/21/2006
Decision Date 10/30/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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