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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 K062959
Device Name DMS 300-2, 300-3 AND 300-4
Applicant
Diagnostic Monitoring Software
292 Kingsbury Grade, #32
P.O. Box 3109
Stateline,  NV  89449
Applicant Contact WILLIAM PARSONS
Correspondent
Diagnostic Monitoring Software
292 Kingsbury Grade, #32
P.O. Box 3109
Stateline,  NV  89449
Correspondent Contact WILLIAM PARSONS
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received09/29/2006
Decision Date 10/16/2006
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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