510(k) DEN200038
DEN200038 is an FDA 510(k) premarket notification submitted by Continuse Biometrics , Ltd. for the device "Gili Pro BioSensor (also known as Gili BioSensor System)". The FDA issued a decision of De Novo Granted on April 1, 2021. The device falls under product code QOK (Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate), a Class II device regulated under 21 CFR 870.2786.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 1, 2021
- Date Received
- June 12, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
- Device Class
- Class II
- Regulation Number
- 870.2786
- Review Panel
- CV
- Submission Type
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.