Oxehealth Vital Signs is an AI-enabled medical device from Oxehealth Limited, listed by FDA (510(k), K220899) with a decision date of 2022-04-29. Review panel: Cardiovascular.
| FDA submission number | K220899 |
|---|---|
| Pathway | 510(k) |
| Company | Oxehealth Limited |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2022-04-29 |
| 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) | 32 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.