K242793

Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1.

510(k) 号: K242793
器械名称: Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1.
申请人: Shenzhen Insighters Medical Technology Co., Ltd. CN
产品代码: EOQ — Bronchoscope (Flexible Or Rigid)
批准日期: 2025-05-28
受理日期: 2024-09-16
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Ear, Nose, Throat

PDF下载 510(k) Summary本站存档 · 2.8 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242793.pdf

FDA 官方记录： K242793

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。