Analyzer, Gas, Nitrogen, Gaseous-Phase
The Gaseous-Phase Nitrogen Analyzer is an anesthesiology device that measures the concentration of nitrogen in the gas phase of a breathing circuit or respiratory sample, used to detect nitrogen washout and monitor inspired gas composition during anesthesia or respiratory testing. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCI, regulated under 21 CFR 868.1690, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CCI
- Device Class
- FDA class 2
- Regulation Number
- 868.1690
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.