FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Tinnitus Therapy
K Number: K260614
·
Decision Jun 10, 2026
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
1
Review Days
105
Basic Information
- Device Name
- Tinnitus Therapy
- K Number
- K260614
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sivantos GmbH
- Date Received
- February 25, 2026
- Decision Date
- June 10, 2026
- Product Code
- KLW
- 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 |
|---|---|---|---|
| KLW | Masker, Tinnitus | FDA class 2 | Ear, Nose, Throat |
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