Data / Medical devices / United Kingdom / NIOX Group Plc
NIOX Group Plc: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 6 510(k) clearances
NIOX Group Plc is registered with the FDA (registration 3012926714) in Oxford Oxfordshire, United Kingdom. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated November 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012926714
- Address
- Magdalen Centre 1 Robert Robinson Avenue, Oxford Oxfordshire, United Kingdom, OX4 4GA
- Owner or operator
- Circassia Inc (9057041)
- Roles
- Specification developer
- First device listed
- February 28, 2008
- Registered through
- 2026
- Brand names listed
- NIOX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Breath Nitric Oxide | MXA | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 22, 2017 | K170983 | NIOX VERO | MXA | Substantially Equivalent | Circassia AB | accessdata.fda.gov |
| February 26, 2015 | K150233 | NIOX VERO Airway Inflammation Monitor | MXA | Substantially Equivalent | Aerocrine AB | accessdata.fda.gov |
| November 6, 2014 | K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | MXA | Substantially Equivalent | Aerocrine AB | accessdata.fda.gov |
| December 27, 2012 | K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | MXA | Substantially Equivalent | Aerocrine AB | accessdata.fda.gov |
| September 2, 2010 | K101034 | NIOX MINO MODEL 09-1000 | MXA | Substantially Equivalent | Aerocrine AB | accessdata.fda.gov |
| March 3, 2008 | K072816 | NIOX MINO | MXA | Substantially Equivalent | Aerocrine AB | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2017. 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.