TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)
FDA 510(k) K122214 · Nihon Kohden Corp.
510(k) numberK122214
Submission
- Device name
- TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)
- Applicant
- Nihon Kohden Corp.
Foothill, CA, US - Received
- July 25, 2012
- Decision date
- May 21, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | 06/10/2025SE |
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| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…KOI · Traditional | 05/02/2021SE |
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Questions and answers
When was TG-970P Sensor Kit W/ New Airway Adapter (YG-213T) cleared by the FDA?
TG-970P Sensor Kit W/ New Airway Adapter (YG-213T) (K122214) received a 510(k) decision of Substantially Equivalent on May 21, 2013, 300 days after the submission was received.
What is the product code of K122214?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.