Tinnitus Therapy— 510(k) K260614

Substantially Equivalent

Sivantos GmbH

FDA 510(k) clearance K260614 for Tinnitus Therapy, Substantially Equivalent on 2026-06-10. Applicant: Sivantos GmbH.

Clearance details

Applicant: Sivantos GmbH
Product code: Code KLW
Advisory panel: Ear, Nose, Throat
Date received: 2026-02-25
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Erlangen, DE

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