510(k) clearance
Echo-2
- 510(k) number
- K254240
- Applicant
- Neko Health AB
- Decision date
- Sep 22, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QOK
- Device type
- Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
- Device class
- Class II
- Regulation
- 21 CFR 870.2786
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Danderyd, SE