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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K172182
Device Name QUANTIEN Measurement System
Applicant
St. Jude Medical (Now Part of the Abbott Medical)
One St. Jude Medical Device
St. Paul,  MN  55117
Applicant Contact Julie Dalquist
Correspondent
St. Jude Medical (Now Part of the Abbott Medical)
One St. Jude Medical Device
St. Paul,  MN  55117
Correspondent Contact Julie Dalquist
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DSK  
Date Received07/19/2017
Decision Date 08/18/2017
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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