Natus Neurology Incorporated
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0946-2013 | Class II | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel a | February 27, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243982 | Nicolet EDX | January 22, 2025 |
| K243495 | Natus Ultrapro S100 (982A0594) | December 12, 2024 |
| K173366 | NicoletOne | July 20, 2018 |
| K172743 | Natus VikingQuest | December 19, 2017 |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | May 2, 2013 |