Data / Medical devices / United Kingdom / Cambridge Cognition Ltd.
Cambridge Cognition Ltd.: FDA-registered device maker in Bottisham Cambridgeshire, United Kingdom, 1 510(k) clearance
Cambridge Cognition Ltd. is registered with the FDA (registration 3008394853) in Bottisham Cambridgeshire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008394853
- Address
- Tunbridge Court, Tunbridge Lane, Bottisham Cambridgeshire, United Kingdom, CB25 9TU
- Owner or operator
- Cambridge Cognition Ltd. (10055776)
- Roles
- Manufacturer
- First device listed
- October 19, 2017
- Registered through
- 2026
- Brand names listed
- CANTAB Insight, Cantab Mobile
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Cognitive Assessment Aid | PKQ | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid, Exempt | PTY | 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 |
|---|---|---|---|---|---|---|
| January 13, 2017 | K161328 | Cantab Mobile | PKQ | Substantially Equivalent | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Computerized Cognitive Assessment Aid, Exempt
- All makers of Computerized Cognitive Assessment Aid
Updated January 13, 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.