ReddyPort NIV Access Elbow
K号: K171827 · 2018-01-19
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决定日期2018-01-19
产品代码MNS
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
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器械摘要
ReddyPort NIV Access Elbow is the device name listed in this FDA 510(k) record. The listed applicant is Smd Manufacturing, LLC. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171827. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the ReddyPort NIV Access Elbow?
ReddyPort NIV Access Elbow is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Smd Manufacturing, LLC. The 510(k) number is K171827.
When did ReddyPort NIV Access Elbow receive FDA 510(k) clearance?
ReddyPort NIV Access Elbow received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171827.
Who is the listed applicant for ReddyPort NIV Access Elbow?
The FDA 510(k) record lists Smd Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReddyPort NIV Access Elbow?
The FDA product code for ReddyPort NIV Access Elbow is MNS. This falls under the Neurology category.
相关临床试验
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列明Smd Manufacturing, LLC为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：MNS）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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