Gili Pro BioSensor (also known as “Gili BioSensor System”) is an AI-enabled medical device from ContinUse Biometrics Ltd., listed by FDA (De Novo, DEN200038) with a decision date of 2021-04-01. Review panel: Cardiovascular.
| FDA submission number | DEN200038 |
|---|---|
| Pathway | De Novo |
| Company | ContinUse Biometrics Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2021-04-01 |
| Decision | Unknown |
| Product code | QOK |
| Classification | Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate |
| Device class | 2 |
| Regulation number | 870.2786 |
| Review time (calendar days) | 293 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.