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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K250415
Device Name G0 Blood Pressure Monitoring System (G0)
Applicant
Aktiia SA
Rue Du Bassin 8a
Neuchatel,  CH 2000
Applicant Contact Neil Puri
Correspondent
Aktiia SA
Rue Du Bassin 8a
Neuchatel,  CH 2000
Correspondent Contact Neil Puri
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/13/2025
Decision Date 07/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06565780
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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