(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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 66 FR 38809, July 25, 2001]
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.