Data / Medical devices / United Kingdom / United Hayek Industries Manufacturing Ltd
United Hayek Industries Manufacturing Ltd: FDA-registered device maker in London Barnet, United Kingdom, 1 510(k) clearance
United Hayek Industries Manufacturing Ltd is registered with the FDA (registration 3008808130) in London Barnet, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2008. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008808130
- Address
- 10 Downage, London Barnet, United Kingdom, NW4 1AA
- Owner or operator
- United Hayek Industries Manufacturing Ltd (10034905)
- Roles
- Manufacturer
- First device listed
- January 14, 2011
- Registered through
- 2026
- Brand names listed
- Hayek Oscillator, Hayek RTX Respirator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, External Body, Negative Pressure, Adult (Cuirass) | BYT | 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 |
|---|---|---|---|---|---|---|
| October 8, 2008 | K082657 | RTX RESPIRATOR | BYT | Substantially Equivalent | Medivent Limited | accessdata.fda.gov |
Compare with other makers
Updated October 8, 2008. 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.