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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K083749
Device Name CARDIOVIEW32 REVIEW MODULE
Applicant
Qrs Diagnostic, LLC
14755 27th Ave.North
Plymouth,  MN  55447
Applicant Contact MARY KAY JENSEN
Correspondent
Qrs Diagnostic, LLC
14755 27th Ave.North
Plymouth,  MN  55447
Correspondent Contact MARY KAY JENSEN
Classification Product Code
LOS
Date Received12/17/2008
Decision Date 03/10/2009
Decision Substantially Equivalent (SESE)
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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