Monitor, Oxygen, Cutaneous, for Infant Not Under Gas Anesthesia

What Is FDA Product Code KLK?

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia is FDA product code KLK, Class 2, 21 CFR 868.2500.

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 3 recalls under this product code since 2005. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.