K250380

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

510(k) 号: K250380
器械名称: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
申请人: Surgify Medical OY FI
产品代码: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
批准日期: 2025-03-13
受理日期: 2025-02-11
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Neurology

也可从 FDA 官方下载： K250380.pdf

FDA 官方记录： K250380

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。