21 CFR 874.1090 - Auditory impedance tester.

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§ 874.1090 Auditory impedance tester.

(a) Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

(b) Classification. Class II.

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United States Code

Title 21 published on 2015-04-01

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

  • 2015-08-04; vol. 80 # 149 - Tuesday, August 4, 2015
    1. 80 FR 46192 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 4, 2015. The classification was applicable on March 6, 2015.
      21 CFR Part 874