21 CFR 870.2860 - Heart sound transducer.

§ 870.2860 Heart sound transducer.
(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.
(b) Classification. Class II (performance standards).

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 870 after this date.

  • 2014-09-15; vol. 79 # 178 - Monday, September 15, 2014
    1. 79 FR 54927 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments on the proposed order by December 15, 2014. See section XII for the effective date of any final order that may publish based on this proposed order.
      21 CFR Part 870