NVO — Spacer, Direct Patient Interface Class II

FDA Device Classification

Classification Details

Product Code: NVO
Device Class: Class II
Regulation Number: 868.5630
Submission Type
Review Panel: AN
Medical Specialty: Anesthesiology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K101532	pharmacaribe	NESSI OTC SPACER	September 1, 2010
K091862	pharmacaribe	NESSI SPACER	November 20, 2009