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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K233266
Device Name MEDIBLU ECG SYSTEM
Applicant
Mediblu Medical, LLC
3016 NW 82nd Ave.
Doral,  FL  33122
Applicant Contact Fernando Ramon
Correspondent
Sigma Biomedical
490 Sawgrass Corporate Pkwy.
Suite 130
Sunrise,  FL  33325
Correspondent Contact Jorge Millan
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/29/2023
Decision Date 06/12/2024
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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