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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 K253463
Device Name ILR ECG Analyzer (IM007)
Applicant
Implicity, Inc.
185 Alewife Brook Pkwy., Suite 210
Cambridge,  MA  02138
Applicant Contact Caroline Florequin
Correspondent
Implicity, Inc.
185 Alewife Brook Pkwy., Suite 210
Cambridge,  MA  02138
Correspondent Contact Caroline Florequin
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received10/08/2025
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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