Data / Medical devices / United Kingdom / Inotec Amd Ltd.
Inotec Amd Ltd.: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 1 510(k) clearance
Inotec Amd Ltd. is registered with the FDA (registration 3014767695) in Cambridge Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 3, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014767695
- Address
- Ground Floor Unit 7340, Building 7300, Cambridge Research Park Waterbeach, Cambridge Cambridgeshire, United Kingdom, CB25 9PD
- Owner or operator
- Inotec AMD Ltd. (10058459)
- Roles
- Manufacturer
- First device listed
- October 3, 2018
- Registered through
- 2026
- Brand names listed
- NATROX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Oxygen, Topical, Extremity | KPJ | 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 |
|---|---|---|---|---|---|---|
| July 3, 2012 | K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | KPJ | Substantially Equivalent | Inotec Amd , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 3, 2012. 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.