Adaptor, Lead Switching, Electrocardiograph

What Is FDA Product Code DRW?

Adaptor, Lead Switching, Electrocardiograph is FDA product code DRW, Class 2, 21 CFR 870.2350.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.