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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K030535
Device Name EKGCARD SYSTEM
Applicant
Qrs Diagnostic, LLC
14755 27th Ave.North
Plymouth,  MN  55447
Applicant Contact BRAD SORENSON
Correspondent
Bsi Healthcare
Kitemark Ct., Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/20/2003
Decision Date 06/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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