DEN200038 is an FDA 510(k) submission for the Gili Pro BioSensor (also known as “Gili BioSensor System”). This device is classified as a Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate (Class II - Special Controls, product code QOK).
Submitted by Continuse Biometrics , Ltd. (Tel-Aviv, IL). The FDA issued a Not Cleared (DENG) decision on April 1, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2786. 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..
| 510(k) Number | DEN200038 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 12, 2020 |
| Decision Date | April 01, 2021 |
| Days to Decision | 293 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QOK - Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2786 |
| 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. |