Nihon Kohden Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulat | October 9, 2025 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | June 10, 2025 |
| K223567 | CNS-2101 Central Monitor | July 31, 2023 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | July 21, 2022 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE | December 29, 2021 |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring | July 16, 2021 |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | May 2, 2021 |
| K191975 | Elefix V Paste for EEG & EMG | February 7, 2020 |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | May 28, 2019 |
| K183529 | AE-120A EEG Head Set | March 19, 2019 |
| K171765 | Nihon Kohden CO2 Monitor | October 11, 2017 |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | August 25, 2017 |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | May 19, 2017 |
| K163459 | Nihon Kohden Vital Sign Telemeter | April 4, 2017 |
| K161860 | TG-970P CO2 Sensor Kit | February 24, 2017 |
| K153707 | Nihon Kohden Vital Sign Telemeter | September 2, 2016 |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | April 8, 2016 |
| K142624 | Neuromaster G1 MEE200 | April 24, 2015 |