iTOF®— 510(k) K242525
Substantially EquivalentNerbio Medical Software Platforms, Inc.
FDA 510(k) clearance K242525 for iTOF®, Substantially Equivalent on 2024-12-05. Applicant: Nerbio Medical Software Platforms, Inc.. Device class: 2.
Clearance details
- Applicant
- Nerbio Medical Software Platforms, Inc.
- Product code
- Code KOI
- Device class
- Class 2
- Regulation
- 21 CFR 868.2775
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code KOI
view all- K261098 — TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
- K250887 — Neuromuscular Transmission Monitor TOF3D (2510091)
- K243339 — WiTOF
- K220530 — Tetragraph Neuromuscular Transmission Monitor
- K220976 — Life Scope PT BSM-1700 Series Bedside Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.