Spirometer, Diagnostic

How Is BZG Classified?

Spirometer, Diagnostic is FDA product code BZG, Class 2, 21 CFR 868.1840.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 366 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Software design (1).

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