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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K133014
Device Name DMS 300-2W HOLTER ECG RECORDER
Applicant
Diagnostic Monitoring Software
290 Kingsbury Grade # 3
Stateline,  NV  89449
Applicant Contact WILLIAM PARSONS
Correspondent
Diagnostic Monitoring Software
290 Kingsbury Grade # 3
Stateline,  NV  89449
Correspondent Contact WILLIAM PARSONS
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received09/25/2013
Decision Date 05/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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