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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K260075
Device Name eClinics
Applicant
Ceiba Healthcare US, Inc.
250 Park Ave. 7th Floor Suite 7012
New York,  NY  10177
Applicant Contact Afsin Alp
Correspondent
Innolitics, LLC
1101 W. 34th St. #550
Austin,  TX  78705
Correspondent Contact Mary Vater
Regulation Number870.2300
Classification Product Code
MSX  
Date Received01/12/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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