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- Subpart B—Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Generator, Electronic Noise (For Audiometric Testing)
- Page Type
- Product Code
- Regulation Medical Specialty
- Ear, Nose, Throat
- Review Panel
- Ear, Nose, Throat
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 874.1120
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 874.1120 Electronic noise generator for audiometric testing
§ 874.1120 Electronic noise generator for audiometric testing.
(a) Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.
(b) Classification. Class II (special 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 84 FR 71813, Dec. 30, 2019]