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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medium-term adjunctive predictive cardiovascular indicator
510(k) Number K230842
Device Name SignalHF (IM008)
Applicant
Implicity Inc.
185 Alewife Brook Parkway
Suite 210
Cambridge,  MA  02138
Applicant Contact Caroline Florequin
Correspondent
Implicity Inc.
185 Alewife Brook Parkway
Suite 210
Cambridge,  MA  02138
Correspondent Contact Caroline Florequin
Regulation Number870.2210
Classification Product Code
QNL  
Subsequent Product Code
QAQ  
Date Received03/28/2023
Decision Date 10/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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