Tinnitus Therapy— 510(k) K260614
Substantially EquivalentSivantos GmbH
FDA 510(k) clearance K260614 for Tinnitus Therapy, Substantially Equivalent on 2026-06-10. Applicant: Sivantos GmbH. Device class: 2.
Clearance details
- Applicant
- Sivantos GmbH
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Erlangen, DE
Recent devices under product code KLW
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