510(k) K254240
- Device
- Echo-2
- Applicant
- Neko Health AB
- 510(k) number
- K254240
- Product code
- QOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-22
- Date received
- 2025-12-29
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Per Sundström
- Address
- Svärdvägen 19 Danderyd SE 182 33 182 33
FDA Registration Numbers#
- 3042165671
Source Documents#
Other 510(k) Records For Product Code QOK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”) | Continuse Biometrics , Ltd. | 2021-04-01 |