510(k) K232159— QEVO System
Substantially EquivalentCarl Zeiss Meditec, AG
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code GWG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Oberkochen, DE
Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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.