PKQ
- 产品代码
- PKQ
- 器械名称
- Computerized Cognitive Assessment Aid
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.1470
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
FDA 分类定义
The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time
FDA 官方分类页： PKQ
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。