StacksVerified U.S. regulatory reference

21 CFR §870.2860

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.
  2. (b)Classification. Class II (performance standards).