Data / Medical devices / Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry (QWE): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Hyperoxia Monitoring Device Adjunct To Pulse Oximetry (product code QWE, Class 2, 21 CFR 870.2720). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 12, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QWE
- Device class
- 2
- Regulation
- 870.2720
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Mexico | 1 |
| United States | 1 |
| Malaysia | 1 |
Makers of Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 1 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 1 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
Updated October 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.