K242453

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

510(k) 号: K242453
器械名称: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
申请人: Terragene S.A. AR
产品代码: FRC — Indicator, Biological Sterilization Process
批准日期: 2024-12-12
受理日期: 2024-08-19
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 0.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242453.pdf

FDA 官方记录： K242453

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。