§ 874.1100. Earphone cushion for audiometric testing.
93 words·~1 min read·
/us/cfr/t21/s§ 874.1100·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.
(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 § 874.9. [51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000]