21 CFR 868.5630 — Nebulizer (Direct Patient Interface)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5630

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CAFNebulizer (Direct Patient Interface)2507
NVOSpacer, Direct Patient Interface22
NVPHolding Chambers, Direct Patient Interface216
SFPVentilator-Compatible Nebulizer22
Innolitics

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