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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
510(k) Number K253516
Device Name Assert-IQ (DM5100)
Applicant
Abbott Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Komal Panchal
Correspondent
Abbott Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Komal Panchal
Regulation Number870.1025
Classification Product Code
MXD  
Date Received11/12/2025
Decision Date 12/18/2025
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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