21 CFR 868.5640 — Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5640
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 62 |
