KOI — Stimulator, Nerve, Peripheral, Electric Class II
FDA Device Classification
Classification Details
- Product Code
- KOI
- Device Class
- Class II
- Regulation Number
- 868.2775
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K250887 | mipm mammendorfer institut für physik und medizin | Neuromuscular Transmission Monitor TOF3D (2510091) | October 21, 2025 |
| K243339 | idmed | WiTOF | June 23, 2025 |
| K242525 | nerbio medical software platforms | iTOF® | December 5, 2024 |
| K220530 | senzime | Tetragraph Neuromuscular Transmission Monitor | August 17, 2022 |
| K220976 | nihon kohden corporation | Life Scope PT BSM-1700 Series Bedside Monitor | July 21, 2022 |
| K212434 | mipm mammendorfer institut für physik und medizin | Neuromuscular Transmission Monitor TOF3D | May 5, 2022 |
| K213316 | nihon kohden corporation | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM | December 29, 2021 |
| K201949 | nihon kohden corporation | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scop | May 2, 2021 |
| K192958 | blink device | TwitchView System | April 2, 2020 |
| K190795 | senzime | Tetragraph Neuromuscular Transmission Monitor | October 18, 2019 |
| K172690 | idmed | ToFscan | May 31, 2018 |
| K172843 | blink device corporation | TwitchView System | March 29, 2018 |
| K162048 | halyard health - irvine | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | December 5, 2016 |
| K051635 | ge healthcare | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | July 15, 2005 |
| K042003 | draeger medical systems | INFINITY TRIDENT NMT POD | September 1, 2004 |
| K023342 | hdc | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE | March 2, 2004 |
| K002889 | neotonus | PNS MAGNETIC STIMULATOR SYSTEM | April 6, 2001 |
| K992598 | organon teknika | TOF-WATCH SX | August 30, 1999 |
| K992596 | organon teknika | TOF-WATCH S | August 30, 1999 |
| K972698 | organon teknika | TOF-WATCH | December 16, 1997 |