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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K253306
Device Name BioTracker 2.0
Applicant
Biotracker, LLC
19900 E Country Club Dr., Suite 04
Miami,  FL  33180
Applicant Contact Breno Moreira
Correspondent
Sigma Biomedical
490 Sawgrass Corporate Pkwy.
Suite 130
Sunrise,  FL  33325
Correspondent Contact Jorge Millan
Date Received09/29/2025
Decision Date 06/26/2026
Decision Substantially Equivalent (SESE)
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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