FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
K Number: K243956
·
Decision Jun 10, 2025
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
301
Applicant Total
14
Review Days
169
Basic Information
- Device Name
- TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K Number
- K243956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nihon Kohden Corporation
- Date Received
- December 23, 2024
- Decision Date
- June 10, 2025
- Product Code
- CCK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCK), ordered by most recent decision date.
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
FDA 510(k)
FDA Class 2
·Anesthesiology
AIM (N/A)
FDA 510(k)
FDA Class 2
·Anesthesiology
AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxy2Pro
FDA 510(k)
FDA Class 2
·Anesthesiology
Endure ETCO2/02 Nasal Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
CO2 Mainstream Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Nihon Kohden Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K223567 | CNS-2101 Central Monitor | Jul 31, 2023 | Substantially Equivalent |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Jul 21, 2022 | Substantially Equivalent |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM | Dec 29, 2021 | Substantially Equivalent |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | Jul 16, 2021 | Substantially Equivalent |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | May 2, 2021 | Substantially Equivalent |
| K191975 | Elefix V Paste for EEG & EMG | Feb 7, 2020 | Substantially Equivalent |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | May 28, 2019 | Substantially Equivalent |
| K183529 | AE-120A EEG Head Set | Mar 19, 2019 | Substantially Equivalent |
| K171765 | Nihon Kohden CO2 Monitor | Oct 11, 2017 | Substantially Equivalent |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Aug 25, 2017 | Substantially Equivalent |