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关注：1
2013-05-23 12:21
求翻译：A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed d是什么意思？ 待解决
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A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed d
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2013-05-23 12:21:38
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
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2013-05-23 12:23:18
一个510(k)是一个premarket提交fda要证
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2013-05-23 12:24:58
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2013-05-23 12:26:38
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2013-05-23 12:28:18
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