FDA 510(k) Application Details - K250415

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K250415
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Aktiia SA Rue du Bassin 8a NeuchΓtel 2000 CH Other 510(k) Applications for this Company
Contact	Neil Puri Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2025
Decision Date	07/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review