Planmed Clarity
K号: K163328 · 2017-12-28
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器械摘要
Planmed Clarity is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2017-12-28 under 510(k) number K163328. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Planmed Clarity?
Planmed Clarity is a medical device that received FDA 510(k) clearance on 2017-12-28. The listed applicant is Planmed OY. The 510(k) number is K163328.
When did Planmed Clarity receive FDA 510(k) clearance?
Planmed Clarity received FDA 510(k) clearance on 2017-12-28, under 510(k) number K163328.
Who is the listed applicant for Planmed Clarity?
The FDA 510(k) record lists Planmed OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Planmed Clarity?
The FDA product code for Planmed Clarity is MUE.
相关临床试验
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列明Planmed OY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：MUE）
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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