FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Vibe SF Self-Fitting Hearing Aid
K Number: K220403
·
Decision Aug 12, 2022
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
6
Applicant Total
2
Review Days
182
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Basic Information
- Device Name
- Vibe SF Self-Fitting Hearing Aid
- K Number
- K220403
- 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
- Wsaud A/S
- Date Received
- February 11, 2022
- Decision Date
- August 12, 2022
- Product Code
- QDD
- 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 |
|---|---|---|---|
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Wsaud A/S
| K Number | Device Name | ||
|---|---|---|---|
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Feb 9, 2024 | Substantially Equivalent |