6440 MyLabX90
K号: K230179 · 2023-11-29
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器械摘要
6440 MyLabX90 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K230179. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 6440 MyLabX90?
6440 MyLabX90 is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Esaote, S.p.A.. The 510(k) number is K230179.
When did 6440 MyLabX90 receive FDA 510(k) clearance?
6440 MyLabX90 received FDA 510(k) clearance on 2023-11-29, under 510(k) number K230179.
Who is the listed applicant for 6440 MyLabX90?
FDA 510(k)记录中列出Esaote, S.p.A.为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for 6440 MyLabX90?
The FDA product code for 6440 MyLabX90 is IYN.
相关临床试验
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。
列明Esaote, S.p.A.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：IYN）
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。
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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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