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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K031964
Device Name BPCARD
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
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/25/2003
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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