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全世界都在等的 Apple Watch 心电图,在英国获批可能还要好几年

 5 years ago
source link: http://www.cocoachina.com/apple/20180930/25085.html
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Apple Watch 的 ECG 功能之所以能快速获得美国 FDA(食品药品管理局)批准,依照的是「510(k)条款」,申请的产品只要与证明自己与已合法上市的产品具有相同安全性及有效性即可,因此审批流程大为简化。

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