StacksVerified U.S. regulatory reference

21 CFR §868.1900

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
  2. (b)Classification. Class II (performance standards).