510(k) DEN150004
- Device
- EPIC ClearView System
- Applicant
- Epic Research & Diagnostics, Inc.
- 510(k) number
- DEN150004
- Product code
- PNA
- Decision
- Unknown (DENG)
- Decision date
- 2016-07-15
- Date received
- 2015-01-13
- Regulation
- 882.1561
- Classification name
- Evoked Photon Image Capture Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- NANCY RIZZO
- Address
- 7659 E Pinnacle Peak Rd. Suite 115 Scottsdale AZ US 85255 85255
FDA Registration Numbers#
- 3033858895
Source Documents#
510(k) summary PDF not indicated by FDA