Transmitters and Receivers, Electrocardiograph, Telephone

What Is FDA Product Code DXH?

Transmitters And Receivers, Electrocardiograph, Telephone is FDA product code DXH, Class 2, 21 CFR 870.2920.

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. Chinese applicants hold 1 clearance under this code; the FDA took 30 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2008. 1 was by a company in China. The root causes the FDA records most often are Component design/selection (4), Nonconforming Material/Component (3) and Software change control (1).

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