Devices · ContinUse Biometrics Ltd.

Gili Pro BioSensor (also known as “Gili BioSensor System”)

ContinUse Biometrics Ltd. is listed for Gili Pro BioSensor (also known as “Gili BioSensor System”) (DEN200038). The FDA list gives April 1, 2021 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QOK as “Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate”: The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200038

Official FDA database record

Date of final decision

April 1, 2021

Company on the FDA list

ContinUse Biometrics Ltd.

Lead panel

Cardiovascular

Primary product code

QOK

openFDA device name for the code

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Device class

2

Regulation number

870.2786

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned