Cushion, Earphone (For Audiometric Testing)
The earphone cushion for audiometric testing is an accessory component that fits around or in the ear to ensure a proper acoustic seal between the audiometric earphone and the ear, maintaining test accuracy during audiological evaluations. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The product code is ETT, regulated under 21 CFR 874.1100 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- ETT
- Device Class
- FDA class 1
- Regulation Number
- 874.1100
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.