Life Scope PT BSM-1700 Series Bedside Monitor
FDA 510(k) K220976 · Nihon Kohden Corporation
510(k) numberK220976
Submission
- Device name
- Life Scope PT BSM-1700 Series Bedside Monitor
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- April 4, 2022
- Decision date
- July 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
| 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 |
| K190795 | Tetragraph Neuromuscular Transmission MonitorKOI · Traditional | Senzime AB | 10/18/2019SE |
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| K223567 | CNS-2101 Central MonitorMSX · Traditional | 07/31/2023SE |
| 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 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional | 05/02/2021SE |
| 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 Life Scope PT BSM-1700 Series Bedside Monitor cleared by the FDA?
Life Scope PT BSM-1700 Series Bedside Monitor (K220976) received a 510(k) decision of Substantially Equivalent on July 21, 2022, 108 days after the submission was received.
What is the product code of K220976?
The FDA product code is KOI – Stimulator, Nerve, Peripheral, Electric, a Class II (moderate risk) device regulated under 21 CFR 868.2775.