DeviceClearance

Product code QOK— Cardiovascular

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

Classification name
Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
Device class
Class 2
Regulation
21 CFR 870.2786
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QOK under 21 CFR 870.2786, via openFDA

Market context for product code QOK

FDA has cleared 1 device under product code QOK, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QOK

Recent clearances under product code QOK

Data sourced from openFDA. This site is unofficial and independent of the FDA.