K242525
- 510(k) number
- K242525
- Device name
- iTOF®
- Applicant
- Nerbio Medical Software Platforms, Inc. CA · US
- Product code
- KOI — Stimulator, Nerve, Peripheral, Electric
- Decision date
- 2024-12-05
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K242525.pdf
Official FDA record: K242525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.