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
Applicant Contact#
- Contact
- Sagi Polani
- Address
- Habarzel 32b Tel-Aviv IL 6971048 6971048
FDA Registration Numbers#
- 3042165671
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QOK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254240 | Echo-2 | Neko Health AB | 2026-09-22 |