ToFscan
FDA 510(k) K172690 · Idmed
510(k) numberK172690
Submission
- Device name
- ToFscan
- Applicant
- Idmed
Marseille, FR - Received
- September 6, 2017
- Decision date
- May 31, 2018
- 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 |
| K212434 | Neuromuscular Transmission Monitor TOF3DKOI · Traditional | MIPM Mammendorfer Institut für Physik und… | 05/05/2022SE |
| 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 |
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Questions and answers
When was ToFscan cleared by the FDA?
ToFscan (K172690) received a 510(k) decision of Substantially Equivalent on May 31, 2018, 267 days after the submission was received.
What is the product code of K172690?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.