FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sontro® OTC Hearing Aids (AI)
K Number: K231550
·
Decision Oct 26, 2023
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
8
Applicant Total
1
Review Days
149
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Basic Information
- Device Name
- Sontro® OTC Hearing Aids (AI)
- K Number
- K231550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3325
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soundwave Hearing, LLC
- Date Received
- May 30, 2023
- Decision Date
- October 26, 2023
- Product Code
- QUH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | FDA class 2 | Ear, Nose, Throat |
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