Submission Details
| 510(k) Number | K242525 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2024 |
| Decision Date | December 05, 2024 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
iTOF?
Dec 2024
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K242525 is an FDA 510(k) clearance for the iTOF?, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by Nerbio Medical Software Platforms, Inc. (San Jose, US). The FDA issued a Cleared decision on December 5, 2024, 101 days after receiving the submission on August 26, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.
Device Classification
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.2775 |
Manufacturer
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