510(k) DEN120016
- Device
- DEKA ARM SYSTEM
- Applicant
- Deka Integrated Solutions Corporation
- 510(k) number
- DEN120016
- Product code
- PAE
- Decision
- Unknown (DENG)
- Decision date
- 2014-05-09
- Date received
- 2012-06-15
- Regulation
- 890.3450
- Classification name
- Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Roger Leroux
- Address
- 340 Commercial St. Manchester NH US 03101 03101
FDA Registration Numbers#
- 3015192982
- 1220973
- 3012481940
Source Documents#
510(k) summary PDF not indicated by FDA