21 CFR 884.2900

§ 884.2900 Fetal stethoscope.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 884.2900, § 884.2900 Fetal stethoscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90810
Permanent ID: ys:prov:90810@1
SHA-256: 655cb2543e13b15fede43e0b126cb5a145215d86957d2d9fa1752b7ea80622f4

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Full text

(a) Identification. A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes. (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 the limitations in § 884.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.