Hearing Aid Feature— 510(k) K261187
Substantially EquivalentSamsung 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.
Summary
Samsung Electronics' Hearing Aid Feature is filed under SCR, air-conduction hearing aid software. The name is generic, and the record doesn't name the hardware it works with.
Class II, 21 CFR 874.3335. Ear, Nose, and Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Samsung filed from Suwon-si, South Korea. The decision came 112 calendar days after receipt (April 10 to July 31, 2026).
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Product code SCR
- Device class
- Class 2
- Regulation
- 21 CFR 874.3335
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, KR
Recent devices under product code SCR
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