Ventilator-Compatible Nebulizer

What Is This Device?

The device is intended to deliver nebulized medications through a ventilator breathing circuit.

What Is FDA Product Code SFP?

Ventilator-Compatible Nebulizer is FDA product code SFP, Class 2, 21 CFR 868.5630.

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. 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.