K233022

Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small

510(k) 号: K233022
器械名称: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
申请人: Owens & Minor (O&M) Halyard, Inc. VA · US
产品代码: MSH — Respirator, Surgical
批准日期: 2024-01-12
受理日期: 2023-09-22
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 · 2.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K233022.pdf

FDA 官方记录： K233022

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。