NVO

Spacer, Direct Patient Interface

Product code

NVO

Device name

Spacer, Direct Patient Interface

Device class

Class 2

21 CFR

21 CFR 868.5630

Medical specialty

Anesthesiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.

Definition text from the FDA device classification database (U.S. federal government work, public domain).