Title 21

SECTION 868.5640

868.5640 Medicinal nonventilatory nebulizer (atomizer).

§ 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.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

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