Echo-2— 510(k) K254240
Substantially EquivalentNeko Health AB
FDA 510(k) clearance K254240 for Echo-2, Substantially Equivalent on 2026-09-22. Applicant: Neko Health AB. Device class: 2.
Summary
Echo-2 from Neko Health AB is filed under QOK: hardware and software for optical camera-based measurement of heart rate and respiratory rate. The record doesn't describe the setup beyond what that code name says.
Class II, 21 CFR 870.2786. The Cardiovascular panel reviewed it as a Traditional 510(k).
Neko Health filed from Danderyd, Sweden. Review took 267 days (December 29, 2025 to September 22, 2026).
Clearance details
- Applicant
- Neko Health AB
- Product code
- Product code QOK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2786
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danderyd, SE
Recent devices under product code QOK
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