C2 Nervemonitor System with Accessories
510(k) K111647
C2 Nervemonitor System with Accessories is a Class II device made by inomed Medizintechnik GmbH, cleared under FDA 510(k) K111647 on 6 Oct 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111647 | Date6 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K111647
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWF
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1870
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent