View all text of Subpart F [§ 868.5090 - § 868.5995]
§ 868.5640 - Medicinal nonventilatory nebulizer (atomizer).
(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.