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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 K251221
Device Name Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
Applicant
Abbott
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Wing Yan (Winnie) Yik
Correspondent
Abbott
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Wing Yan (Winnie) Yik
Regulation Number870.1025
Classification Product Code
MXD  
Date Received04/21/2025
Decision Date 09/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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