StacksVerified U.S. regulatory reference

21 CFR §868.5690

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)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.
  2. (b)Classification. Class II (performance standards).