NVO — Spacer, Direct Patient Interface Class II
FDA product code NVO covers "Spacer, Direct Patient Interface", a Class II medical device regulated under 21 CFR 868.5630. Submissions are reviewed by the Anesthesiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.