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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stethoscope, electronic
510(k) Number K170928
Device Name CADence System
Applicant
AUM Cardiovascular, Inc.
1405 Heritage Dr, Suite 100
northfield,  MN  55057
Applicant Contact marie johnson
Correspondent
AUM Cardiovascular, Inc.
1405 Heritage Dr, Suite 100
northfield,  MN  55057
Correspondent Contact marie johnson
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received03/29/2017
Decision Date 08/03/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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