DeviceClearance

Product code NVO— Anesthesiology

NESSI OTC SPACER

Classification name
Spacer, Direct Patient Interface
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NVO under 21 CFR 868.5630, via openFDA

Market context for product code NVO

FDA has cleared 2 devices under product code NVO between 2009 and 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NVO

Recent clearances under product code NVO

Data sourced from openFDA. This site is unofficial and independent of the FDA.