NVO

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Spacer, Direct Patient Interface

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5630

Medical specialty

Anesthesiology

FDA 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.

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