510(k) DEN130033
- Device
- COGNIVUE
- Applicant
- Cerebral Assessment Systems, Inc.
- 510(k) number
- DEN130033
- Product code
- PKQ
- Decision
- Unknown (DENG)
- Decision date
- 2015-06-05
- Date received
- 2013-06-12
- Regulation
- 882.1470
- Classification name
- Computerized Cognitive Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- CHARLES J DUFFY
- Address
- 10 Pond View Dr. Pittsford NY US 14534 14534
FDA Registration Numbers#
- 3008394853
- 3014389576
- 3008660657
Source Documents#
510(k) summary PDF not indicated by FDA