Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

How Is CBQ Classified?

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) is FDA product code CBQ, Class 2, 21 CFR 868.1500.

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.