K253537

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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)

510(k) 号: K253537
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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)
申请人: Bright Uro, Inc. CA · US
产品代码: EXQ — Cystometer, Electrical Recording
批准日期: 2026-04-16
受理日期: 2025-11-13
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 · 0.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K253537.pdf

FDA 官方记录： K253537

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。