Analyzer, Gas, Water Vapor, Gaseous-Phase
The Analyzer, Gas, Water Vapor, Gaseous-Phase is an instrument used to measure the concentration of water vapor in respiratory gas mixtures, providing data relevant to humidification and gas conditioning in anesthesia and respiratory therapy. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BXA, regulated under 21 CFR 868.1975 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BXA
- Device Class
- FDA class 1
- Regulation Number
- 868.1975
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.