Regulations last checked for updates: Apr 30, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 47 FR 31142, July 16, 1982, unless otherwise noted.
cite as: 21 CFR 868.5630