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e-CFR data is current as of April 20, 2021

Title 21Chapter ISubchapter HPart 874Subpart B → §874.1060


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices


§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.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]

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