510(k) K111647— C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

Substantially Equivalent

Inomed Medizintechnik GmbH

Clearance details

Applicant: Inomed Medizintechnik GmbH
Product code: Code GWF
Advisory panel: Neurology
Date received: 2011-06-13
Decision date: 2011-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmendingen, DE

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.