K261187
- 510(k) number
- K261187
- Device name
- Hearing Aid Feature
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- SCR — Air-Conduction Hearing Aid Software
- Decision date
- 2026-07-31
- Date received
- 2026-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K261187.pdf
Official FDA record: K261187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.