C2 NERVEMONITOR SYSTEM WITH ACCESSORIES— 510(k) K111647
Substantially EquivalentInomed Medizintechnik GmbH
FDA 510(k) clearance K111647 for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES, Substantially Equivalent on 2011-10-06. Applicant: Inomed Medizintechnik GmbH. Device class: 2.
Clearance details
- Applicant
- Inomed Medizintechnik GmbH
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emmendingen, DE
Recent devices under product code GWF
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- K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . 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.