COGNIVUE
FDA 510(k) clearance DEN130033 · decided 2015-06-05
Clearance details
- K-number
- DEN130033
- Device name
- COGNIVUE
- Applicant
- Cerebral Assessment Systems, Inc.
- Decision
- Unknown
- Date received
- 2013-06-12
- Decision date
- 2015-06-05
- Days to decision
- 723 days
- Clearance type
- Direct
- Product code
- PKQ
- Device class
- 2
- Regulation number
- 882.1470
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pittsford, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Cantab Mobile (K161328) | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | 2017-01-13 |
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Recalls involving this device
No recalls on record reference this clearance.