DeviceClearance

K150220

Substantially Equivalent

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

Applicant
Eb Neuro S.P.A.
Product code
GWF
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Florence, IT
Download summary PDF View on FDA.gov ↗

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.