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24 天
FDA发布医用脉搏血氧仪最新指南,510K申请或引起大变化!
2025年1月6日,FDA发布《医用脉搏血氧仪 - 非临床和临床性能测试、标签和上市前提交建议》。 FDA发现,在较低的动脉血氧饱和度(SaO2)方面,浅色和深色色素沉着的个体之间存在差异,并就此和各方进行接触,在制定本指南时也酌情考虑相关意见。 指南不涉及 ...
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