K253431

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

510(k) 号: K253431
器械名称: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
申请人: Shokz Health Global Limited HK
产品代码: LXB — Hearing Aid, Bone Conduction
批准日期: 2026-08-19
受理日期: 2025-10-01
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Ear, Nose, Throat

PDF下载 510(k) Summary本站存档 · 0.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K253431.pdf

FDA 官方记录： K253431

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。