Neuromuscular Transmission Monitor TOF3D
FDA 510(k) K212434 · MIPM Mammendorfer Institut für Physik und Medizin GmbH
510(k) numberK212434
Submission
- Device name
- Neuromuscular Transmission Monitor TOF3D
- Applicant
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
Mammendorf, DE - Received
- August 4, 2021
- Decision date
- May 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOI – Stimulator, Nerve, Peripheral, Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code KOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…KOI · Special | Senzime AB | 05/22/2026SE |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091)KOI · Traditional | MIPM Mammendorfer Institut für Physik und… | 10/21/2025SE |
| K243339 | WiTOFKOI · Traditional | Idmed | 06/23/2025SE |
| K242525 | iTOF®KOI · Traditional | Nerbio Medical Software Platforms, Inc. | 12/05/2024SE |
| K220530 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 08/17/2022SE |
| K220976 | Life Scope PT BSM-1700 Series Bedside MonitorKOI · Special | Nihon Kohden Corporation | 07/21/2022SE |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…KOI · Special | Nihon Kohden Corporation | 12/29/2021SE |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional | Nihon Kohden Corporation | 05/02/2021SE |
| K192958 | TwitchView SystemKOI · Special | Blink Device Company | 04/02/2020SE |
| K190795 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 10/18/2019SE |
More from Senzime AB
| 510(k) | Device | Decision |
|---|---|---|
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091)KOI · Traditional | 10/21/2025SE |
Questions and answers
When was Neuromuscular Transmission Monitor TOF3D cleared by the FDA?
Neuromuscular Transmission Monitor TOF3D (K212434) received a 510(k) decision of Substantially Equivalent on May 5, 2022, 274 days after the submission was received.
What is the product code of K212434?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.