Cardiology
Vital Signs
Oxehealth Limited
FDA
FDA-cleared AI medical device
The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
FDA Submission Metadata
- Submission number
- K243687
- Decision date
- August 2025
- FDA panel
- Cardiovascular
- Product code
- QME
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K243687
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.