Clearance Summary
iTOF® received FDA 510(k) clearance under submission number K242525, sponsored by Nerbio Medical Software Platforms, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2024-12-05.
- Submission: K242525
- Applicant / Sponsor: Nerbio Medical Software Platforms, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 2024-12-05
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.