§874.1060. Acoustic chamber for audiometric testing.
21 C.F.R. § 874.1060
Identification. An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
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 § 874.9.
Notes, amendments, and revision history
Amendments
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]