DeviceClearance

K211291

Substantially Equivalent

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D

Applicant
Fiagon GmbH
Product code
PGW
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hennigsdorf, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code PGW

product code PGW
Malfunction
1,199
Total
1,199

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.