DeviceClearance

K234080

Substantially Equivalent

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

Applicant
Soterix Medical, Inc.
Product code
GWF
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Woodbridge, NJ, US
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.