21 CFR § 868.5630 Anesthesiology Devices

§ 868.5630 Nebulizer.

Current through Sep 8, 2026 · Read all of Part 868

(a) 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.

(b) Classification. Class II (performance standards).

← § 868.5620 Breathing mouthpiece.§ 868.5640 Medicinal nonventilatory nebulizer (atomizer). →