QCJ

Closed Loop Auto Titration Device For Oral Appliances

产品代码: QCJ
器械名称: Closed Loop Auto Titration Device For Oral Appliances
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 872.5571
FDA 专业组: Dental
上市路径: 需提交 510(k) 上市前通告
FDA 历史累计 510(k): 1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patients respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： QCJ

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。