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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Cardiac Amyloidosis Status Indicator
510(k) Number K250151
Device Name Us2.ca
Applicant
Eko.Ai Pte Ltd. D/B/A Us2.Ai
2 College Rd., 02-00
Singapore,  SG 169850
Applicant Contact Hui Qun Tay
Correspondent
Eko.Ai Pte Ltd. D/B/A Us2.Ai
2 College Rd., 02-00
Singapore,  SG 169850
Correspondent Contact Hui Qun Tay
Regulation Number870.2200
Classification Product Code
SDJ  
Date Received01/21/2025
Decision Date 06/20/2025
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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