21 CFR 874.1050 - Audiometer.

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§ 874.1050 Audiometer.

(a)Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

(b)Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.

[ 51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 874 after this date.

  • 2016-10-24; vol. 81 # 205 - Monday, October 24, 2016
    1. 81 FR 73028 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 24, 2016. The classification was applicable on September 16, 2016.
      21 CFR Part 874