510(k) K141208
- Device
- DYNAMIC NEUROSCREENING DEVICE
- Applicant
- Prosenex
- 510(k) number
- K141208
- Product code
- LQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-23
- Date received
- 2014-05-09
- Regulation
- 882.1200
- Classification name
- Test, Temperature Discrimination
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM G MCLAIN
- Address
- 342 E. Main St. Suite 207 Leola PA US 17540 17540
FDA Registration Numbers#
- 3027555919
- 3007674911
- 8044062
- 3027307766