Protector, Hearing (Circumaural)
The circumaural hearing protector is a muff-style device worn over the entire outer ear to attenuate environmental noise and protect hearing from damage from excessive sound exposure. This product code (EWE) is currently FDA unclassified, meaning the device has not been formally assigned to Class 1, 2, or 3 and is pending classification. The product code is EWE, reviewed by the Ear, Nose, Throat panel; no regulation number or medical specialty is on record. No implant or life-sustaining flags apply.
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Basic Information
- Product Code
- EWE
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935160 | MINIMUFFS | Feb 09, 1995 | Substantially Equivalent | Natus Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.