StacksVerified U.S. regulatory reference

21 CFR §874.1925

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.
  2. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.