Submission Details
| 510(k) Number | K111647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 13, 2011 |
| Decision Date | October 06, 2011 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
Oct 2011
Decision
115d
Days
Class 2
Risk
About This 510(k) Submission
K111647 is an FDA 510(k) clearance for the C2 NERVEMONITOR SYSTEM WITH ACCESSORIES, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on October 6, 2011, 115 days after receiving the submission on June 13, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.
Device Classification
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1870 |
Manufacturer
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