Nihon Kohden CO2 Sensor Kit, Model TG-970P
FDA 510(k) K083456 · Nihon Kohden America, Inc.
510(k) numberK083456
Submission
- Device name
- Nihon Kohden CO2 Sensor Kit, Model TG-970P
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- November 21, 2008
- Decision date
- March 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Nihon Kohden CO2 Sensor Kit, Model TG-970P cleared by the FDA?
Nihon Kohden CO2 Sensor Kit, Model TG-970P (K083456) received a 510(k) decision of Substantially Equivalent on March 2, 2009, 101 days after the submission was received.
What is the product code of K083456?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.