Is Masimo Professional or Personal Health FDA approved or cleared?
Partly. Masimo Professional or Personal Health belongs to a product family by Masimo Corporation that holds a De Novo authorisation, latest decision in 2023, but this exact variant or app is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Masimo Professional or Personal Health |
|---|---|
| Maker | Masimo Corporation |
| Care area | Vital signs & remote monitoring |
| What it does | Professional-grade pulse oximetry and monitoring solutions |
| FDA | De Novo, latest decision 2023 (product family) |
| Verification level | Product family authorised; this exact variant or app is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | masimo.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes