Spacer, Direct Patient Interface
The Direct Patient Interface Spacer is a device used with nebulizers and metered dose inhalers, comprising a reservoir into which aerosol medication is dispensed before the patient inhales it through an open mouthpiece. Spacers are designed to minimize delivery of large aerosolized particles to the airways, improving medication deposition in the lungs. It is an FDA Class 2 device regulated under 21 CFR 868.5630 in the Anesthesiology specialty, with product code NVO, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NVO
- Device Class
- FDA class 2
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.