Data / Medical devices / United Kingdom / Oxehealth Ltd
Oxehealth Ltd: FDA-registered device maker in Abingdon Oxfordshire, United Kingdom, 2 510(k) clearances
Oxehealth Ltd is registered with the FDA (registration 3019791389) in Abingdon Oxfordshire, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019791389
- Address
- Bee House 140 Eastern Avenue; Oxford, Abingdon Oxfordshire, United Kingdom, OX14 4SB
- Owner or operator
- Oxehealth Ltd (10082091)
- Roles
- Manufacturer
- First device listed
- June 15, 2021
- Registered through
- 2026
- Brand names listed
- Oxevision Sleep System, Vital Signs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Sleep Assessment | LEL | 2 | Manufacturer | accessdata.fda.gov |
| Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | QME | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2024 | K233618 | Oxevision Sleep Device | LEL | Substantially Equivalent | Oxehealth Limited | accessdata.fda.gov |
| March 26, 2021 | DEN200019 | Oxehealth Vital Signs | QME | Unknown | Oxehealth Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Sleep Assessment
- All makers of Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Updated April 3, 2024. 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.