StacksVerified U.S. regulatory reference

21 CFR §868.1840

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
  2. (b)Classification. Class II (performance standards).