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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
Applicant
Danmedical Limited
The Greenhouse, Beechwood
Business Park
Inverness Highlands,  GB
Applicant Contact IAN DRYSDALE
Correspondent
Danmedical Limited
The Greenhouse, Beechwood
Business Park
Inverness Highlands,  GB
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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