K251967

HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

510(k) 号: K251967
器械名称: HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
申请人: O&M Halyard, Inc. GA · US
产品代码: FXX — Mask, Surgical
批准日期: 2026-03-18
受理日期: 2025-06-26
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

PDF下载 510(k) Summary本站存档 · 0.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K251967.pdf

FDA 官方记录： K251967

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。