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FDA Product Code

FDA Product Code QOK — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.2786

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K254240 Echo-2 Neko Health AB 2026-09-22 Traditional PDF ↗
DEN200038 Gili Pro BioSensor (also known as “Gili BioSensor System”) Continuse Biometrics , Ltd. 2021-04-01 Direct —

Product code QOK · Class II · Cardiovascular. Data: openFDA.