21 CFR 868.5690 — Spirometer, Therapeutic (Incentive)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5690
Identification
An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 108 | 3rd Party |
