Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
FDA 510(k) K201949 · Nihon Kohden Corporation
510(k) numberK201949
Submission
- Device name
- Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- July 13, 2020
- Decision date
- May 2, 2021
- 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
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|---|---|---|---|
| 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 |
| K192958 | TwitchView SystemKOI · Special | Blink Device Company | 04/02/2020SE |
| K190795 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 10/18/2019SE |
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| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | 06/10/2025SE |
| K223567 | CNS-2101 Central MonitorMSX · Traditional | 07/31/2023SE |
| K220976 | Life Scope PT BSM-1700 Series Bedside MonitorKOI · Special | 07/21/2022SE |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000…KOI · Special | 12/29/2021SE |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside…MHX · Traditional | 07/16/2021SE |
| K191975 | Elefix V Paste for EEG & EMGGYB · Traditional | 02/07/2020SE |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI · Traditional | 05/28/2019SE |
Questions and answers
When was Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series cleared by the FDA?
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (K201949) received a 510(k) decision of Substantially Equivalent on May 2, 2021, 293 days after the submission was received.
What is the product code of K201949?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.