Set, Audiometer Calibration
The audiometer calibration set is a collection of acoustic reference instruments and tools used to verify that audiometers are performing within specified standards, ensuring reliable hearing test results. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission requirement. The product code is EWA, regulated under 21 CFR 874.1080 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EWA
- Device Class
- FDA class 1
- Regulation Number
- 874.1080
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.