21 CFR 884.2900 - Fetal stethoscope.
(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.