Vital Signs is an AI-enabled medical device from Oxehealth Limited, listed by FDA (510(k), K243687) with a decision date of 2025-08-27. Review panel: Cardiovascular.
| FDA submission number | K243687 |
|---|---|
| Pathway | 510(k) |
| Company | Oxehealth Limited |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-08-27 |
| Decision | Substantially Equivalent |
| Product code | QME |
| Classification | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Device class | 2 |
| Regulation number | 870.2785 |
| Review time (calendar days) | 271 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
More devices from Oxehealth Limited · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.