Analyzer, Gas, Water Vapor, Gaseous-Phase
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Hunan.
How Is BXA Classified?
Analyzer, Gas, Water Vapor, Gaseous-Phase is FDA product code BXA, Class 1, 21 CFR 868.1975.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
Name
Record