Electrocardiograph, Ambulatory, With Analysis Algorithm

How Is MLO Classified?

Electrocardiograph, Ambulatory, With Analysis Algorithm is FDA product code MLO, Class 2, 21 CFR 870.2800.

How Does It Reach the US Market?

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. Chinese applicants hold 2 clearances under this code; the FDA took a median of 333 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Software design (2).

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