Spacer, Direct Patient Interface

NVO · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5630

Classification

FDA Product Code: NVO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.5630
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown