868.5630 Nebulizer.§ 868.5630 Nebulizer.
(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).