Hearing Aid Feature— 510(k) K261187

Name: FDA 510(k) clearance K261187
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K261187 for Hearing Aid Feature, Substantially Equivalent on 2026-07-31. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code SCR
Device class: Class 2
Regulation: 21 CFR 874.3335
Advisory panel: Ear, Nose, Throat
Date received: 2026-04-10
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.