Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge

What Is FDA Product Code CCN?

Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge is FDA product code CCN, Class 1, 21 CFR 868.2300.

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.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2009. None was by a company in China. The root cause the FDA records most often is Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.