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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 K100424
Device Name DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
Original Applicant
DANMEDICAL LIMITED
the greenhouse, beechwood
business park
inverness highlands,  GB
Original Contact ian drysdale
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/16/2010
Decision Date 03/21/2011
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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