Submission Details
| 510(k) Number | K152505 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 2015 |
| Decision Date | February 01, 2016 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
C2 NerveMonitor System
Feb 2016
Decision
152d
Days
Class 2
Risk
About This 510(k) Submission
K152505 is an FDA 510(k) clearance for the C2 NerveMonitor System, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Inomed Medizintechnik GmbH (Emmendingen Baden- Wuerttemberg, DE). The FDA issued a Cleared decision on February 1, 2016, 152 days after receiving the submission on September 2, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.
Device Classification
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
Manufacturer
Inomed Medizintechnik GmbH
Emmendingen Baden- Wuerttemberg · DE
SASCHKA BUSCH
10 submissions
10 cleared
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