Data / Medical devices / United Kingdom / Gas Control Equipment Ltd
Gas Control Equipment Ltd: FDA-registered device maker in Haydock St. Helens, United Kingdom, 1 510(k) clearance
Gas Control Equipment Ltd is registered with the FDA (registration 3011895992) in Haydock St. Helens, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011895992
- Address
- 100 Empress Park Penny Lane, Haydock St. Helens, United Kingdom, WA119DB
- Owner or operator
- Gas Control Equipment LTD (10056354)
- Roles
- Specification developer
- First device listed
- December 1, 2017
- Registered through
- 2026
- Brand names listed
- ARYA Zen-O Lite Portable Oxygen Concentrator Model RS-00600, GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C, GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C, GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600, GCE Zen-O Portable Oxygen Concentrator Model RS-00500
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 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 |
|---|---|---|---|---|---|---|
| May 24, 2017 | K162433 | GCE Zen-O Portable Oxygen Concentrator | CAW | Substantially Equivalent | Oxus, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 24, 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.