ExoAtlet-II
K号: K201473 · 2021-07-16
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决定日期2021-07-16
产品代码PHL
咨询委员会PM
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决定实质等同
器械摘要
ExoAtlet-II is the device name listed in this FDA 510(k) record. The listed applicant is Exoatlet Asia Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K201473. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ExoAtlet-II?
ExoAtlet-II is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Exoatlet Asia Co. , Ltd.. The 510(k) number is K201473.
When did ExoAtlet-II receive FDA 510(k) clearance?
ExoAtlet-II received FDA 510(k) clearance on 2021-07-16, under 510(k) number K201473.
Who is the listed applicant for ExoAtlet-II?
The FDA 510(k) record lists Exoatlet Asia Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExoAtlet-II?
The FDA product code for ExoAtlet-II is PHL.
相关临床试验
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相关器械（代码：PHL）
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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