Cognoa, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 3020832299
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
- GUDID
Canvas Dx Ref K243558
510(k) 510(k)Cognoa ASD Diagnosis Aid Ref DEN200069
De Novo 510(k)
Company details
- FDA FEI number
- 3020832299
- DUNS number
- 079400761
- Address
- 5000 Campus Dr, Newport Beach, CA, 92660
- [email protected]
- Phone
- 1-866-426-4662
Frequently asked questions
How many devices does Cognoa, Inc. have in the registry?
The registry currently lists 3 devices for Cognoa, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cognoa, Inc.'s devices?
Among its 3 most recently registered devices, Cognoa, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cognoa, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cognoa, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cognoa, Inc. in the registry?
The most recently registered devices listed for Cognoa, Inc. include Canvas Dx 1.3.0, Canvas Dx and Cognoa ASD Diagnosis Aid.