Analyzer, Gas, Nitrogen, Gaseous-Phase
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
How Is CCI Classified?
Analyzer, Gas, Nitrogen, Gaseous-Phase is FDA product code CCI, Class 2, 21 CFR 868.1690.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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