Planmed Clarity 2D和Clarity S
K号: K192317 · 2020-10-23
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器械摘要
Planmed Clarity 2D and Clarity S is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K192317. 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 2D and Clarity S?
Planmed Clarity 2D and Clarity S is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Planmed OY. The 510(k) number is K192317.
When did Planmed Clarity 2D and Clarity S receive FDA 510(k) clearance?
Planmed Clarity 2D and Clarity S received FDA 510(k) clearance on 2020-10-23, under 510(k) number K192317.
Who is the listed applicant for Planmed Clarity 2D and Clarity S?
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 2D and Clarity S?
The FDA product code for Planmed Clarity 2D and Clarity S 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
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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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