Sv70 Ventilator

What Is FDA Product Code MNT?

Sv70 Ventilator is FDA product code MNT, Class 2, 21 CFR 868.5895.

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. Chinese applicants hold 1 clearance under this code; the FDA took 269 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 64 recalls under this product code since 2003. None was by a company in China. 14 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (45), Nonconforming Material/Component (6) and Process control (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.