Cardiovascular · De Novo · 2021
Gili Pro BioSensor (also known as Gili BioSensor System)
ContinUse Biometrics Ltd.. Granted by FDA on 1 April 2021 under submission DEN200038, product code QOK (hardware and software for optical camera-based measurement of heart rate and respiratory rate). What FDA's record says, in FDA's words.
Device record · DEN200038
- Device. Gili Pro BioSensor (also known as Gili BioSensor System)DEVICE
- Company. ContinUse Biometrics Ltd.COMPANY
- Decision. 1 April 2021, De NovoDECISION
- Panel. CardiovascularPANEL
- Product code. QOK, Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory RateCODE
- Regulation. 21 CFR 870.2786, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The Gili Pro BioSensor (Gili BioSensor System) includes an optical module that is intended to capture motion-vibration signals from an illuminated surface for assessment of physiological information. Such information, captured during spot-measurement, includes: Heart rate Respiratory rate The device is indicated for use by or under the supervision of healthcare professionals for adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes. De Novo Summary (DEN200038) The device should be used while the subject is seated upright either in a chair or in a bed. The information stored on the system may be reviewed by qualified persons.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QOK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QOK, in Cardiovascular, or granted in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.