Natus Ultrapro S100 (982A0594)— 510(k) K243495
Substantially EquivalentNatus Neurology Incorporated
FDA 510(k) clearance K243495 for Natus Ultrapro S100 (982A0594), Substantially Equivalent on 2024-12-12. Applicant: Natus Neurology Incorporated.
Clearance details
- Applicant
- Natus Neurology Incorporated
- Product code
- Code GWF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Middleton, WI, 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.