Spacer, Direct Patient Interface

FDA product code NVO · Class II (moderate risk) · 21 CFR 868.5630 · Anesthesiology

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K101532Nessi OTC SpacerNVO · Traditional Pharmacaribe09/01/2010SE
K091862Nessi SpacerNVO · Traditional Pharmacaribe11/20/2009SE