FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nuheara IQbuds 2 PRO Hearing Aid
K Number: K221064
·
Decision Oct 30, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
8
Applicant Total
1
Review Days
202
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Basic Information
- Device Name
- Nuheara IQbuds 2 PRO Hearing Aid
- K Number
- K221064
- 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
- Nuheara Limited
- Date Received
- April 11, 2022
- Decision Date
- October 30, 2022
- 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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