QEVO System with KINEVO 900— 510(k) K170667
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K170667 for QEVO System with KINEVO 900, Substantially Equivalent on 2017-08-18. Applicant: Carl Zeiss Meditec, AG. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jena, DE
Recent devices under product code GWG
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view allAdverse 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.