6 devices · 1 company · 2021 to 2026
Oxehealth Limited: AI-enabled devices on FDA's list
6 devices from Oxehealth Limited, 2021 to 2026, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Oxehealth Limited
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Vital SignsK251200 · 510(k) | Cardiovascular | QME | database entry | |
| Vital SignsK243687 · 510(k) | Cardiovascular | QME | database entry | |
| Oxevision Sleep DeviceK233618 · 510(k) | Neurology | LEL | database entry | |
| Oxehealth Vital SignsK220899 · 510(k) | Cardiovascular | QME | database entry | |
| Vital SignsK211906 · 510(k) | Cardiovascular | QME | database entry | |
| Oxehealth Vital SignsDEN200019 · De Novo | Cardiovascular | QME | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.