Clearance Summary
Natus Ultrapro S100 (982A0594) received FDA 510(k) clearance under submission number K243495, sponsored by Natus Neurology Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-12-12.
- Submission: K243495
- Applicant / Sponsor: Natus Neurology Incorporated
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2024-12-12
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.