Title 21: Food and Drugs
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/ PART 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart B - Diagnostic Devices / § 874.1060 Acoustic chamber for audiometric testing.
§ 874.1060 Acoustic chamber for audiometric testing.
(a) 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.
(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 § 874.9.