K243052

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))

510(k) 号: K243052
器械名称: Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
申请人: Bright Uro, Inc. CA · US
产品代码: EXQ — Cystometer, Electrical Recording
批准日期: 2025-03-24
受理日期: 2024-09-27
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 2.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243052.pdf

FDA 官方记录： K243052

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。