TwitchView System
FDA 510(k) K192958 · Blink Device Company
510(k) numberK192958
Submission
- Device name
- TwitchView System
- Applicant
- Blink Device Company
Seattle, WA, US - Received
- October 22, 2019
- Decision date
- April 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
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| 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 |
| K190795 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 10/18/2019SE |
More from Senzime AB
| 510(k) | Device | Decision |
|---|---|---|
| K172843 | TwitchView SystemKOI · Traditional | 03/29/2018SE |
Questions and answers
When was TwitchView System cleared by the FDA?
TwitchView System (K192958) received a 510(k) decision of Substantially Equivalent on April 2, 2020, 163 days after the submission was received.
What is the product code of K192958?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.