510(k) DEN200038

Device

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

Applicant

Continuse Biometrics , Ltd.

510(k) number

DEN200038

Product code

QOK

Decision

Unknown (DENG)

Decision date

2021-04-01

Date received

2020-06-12

Regulation

870.2786

Classification name

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

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Direct

Third party reviewed

N