Electrode Measurement, Blood-Gases (Pco2, Po2) and Blood Ph

How Is CHL Classified?

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph is FDA product code CHL, Class 2, 21 CFR 862.1120.

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 364 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 184 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software design (39), Nonconforming Material/Component (32) and Device Design (11).

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