K251611

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

510(k) 号: K251611
器械名称: Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
申请人: Fisher & Paykel Healthcare, Ltd. NZ
产品代码: BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
批准日期: 2025-06-25
受理日期: 2025-05-27
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Anesthesiology

510(k) Summary（FDA 官方 PDF）： K251611.pdf

FDA 官方记录： K251611

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。