C2 NerveMonitor System— 510(k) K152505

Substantially Equivalent

Inomed Medizintechnik GmbH

FDA 510(k) clearance K152505 for C2 NerveMonitor System, Substantially Equivalent on 2016-02-01. Applicant: Inomed Medizintechnik GmbH.

Clearance details

Applicant: Inomed Medizintechnik GmbH
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2015-09-02
Decision date: 2016-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmendingen Baden- Wuerttemberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.