K241799

ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C

510(k) 号: K241799
器械名称: ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
申请人: Atmos Medizintechnik GmbH & Co. KG DE
产品代码: BTA — Pump, Portable, Aspiration (Manual Or Powered)
批准日期: 2025-03-07
受理日期: 2024-06-21
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 · 2.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241799.pdf

FDA 官方记录： K241799

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。