Monitor, Blood-Flow, Ultrasonic

What Is FDA Product Code HEP?

Monitor, Blood-Flow, Ultrasonic is FDA product code HEP, Class 2, 21 CFR 884.2660.

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 29 days from receipt to decision.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.