FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Intrisound Tuned Lumen® 155 Hearing Aids
K Number: K223848
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
8
Applicant Total
1
Review Days
260
Basic Information
- Device Name
- Intrisound Tuned Lumen® 155 Hearing Aids
- K Number
- K223848
- 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
- Tuned Ltd
- Date Received
- December 22, 2022
- Decision Date
- September 8, 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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