JED
- 产品代码
- JED
- 器械名称
- Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
- 管理类别
- 第 3 类（Class III）
- 21 CFR 条款
- 21 CFR 868.1120
- FDA 专业组
- Anesthesiology
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
FDA 官方分类页： JED
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。