DEKA ARM SYSTEM
FDA 510(k) clearance DEN120016 · decided 2014-05-09
Clearance details
- K-number
- DEN120016
- Device name
- DEKA ARM SYSTEM
- Applicant
- Deka Integrated Solutions Corporation
- Decision
- Unknown
- Date received
- 2012-06-15
- Decision date
- 2014-05-09
- Days to decision
- 693 days
- Clearance type
- Post-NSE
- Product code
- PAE
- Device class
- 2
- Regulation number
- 890.3450
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.