青云英语翻译

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510(k)是上市前向FDA证明,在市场上销售的设备是至少在安全和有效的,也就是说,实质上等同,合法销售的设备(21 CFR 807.92(a)项(3))的提交这是不是受PMA。提交者必须比较他们的设备,以一个或更多类似设备的合法销售和支持其实质相当于索赔。具有法律销售的设备,如21 CFR 807.92(a)项(3),是一个合法销售之前,1976年5月28日,(preamendments设备),其中PMA不需要的设备,或设备已从III类重新分类,以II类或I或设备已通过510(K)过程本身。合法销售的设备(S)的等价绘制俗称为“上游”。虽然最近下510清除设备(K)通常被视为等价声称谓词选择

翻译结果4复制译文编辑译文朗读译文返回顶部

一个510(k)是一个premarket提交fda要证
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