MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)— 510(k) K234080
Substantially EquivalentSoterix Medical, Inc.
FDA 510(k) clearance K234080 for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S), Substantially Equivalent on 2024-03-25. Applicant: Soterix Medical, Inc..
Clearance details
- Applicant
- Soterix Medical, Inc.
- Product code
- Code GWF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodbridge, NJ, US
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.