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FDA 510(k)

RedDrop ONE (One)

K号: K234081 · 2024-03-21

申请人Reddrop DX
决定日期2024-03-21
产品代码FMK
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决定Unknown

器械摘要

RedDrop ONE (One) is the device name listed in this FDA 510(k) record. The listed applicant is Reddrop DX. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K234081. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

常见问题

What is the RedDrop ONE (One)?

RedDrop ONE (One) is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Reddrop DX. The 510(k) number is K234081.

When did RedDrop ONE (One) receive FDA 510(k) clearance?

RedDrop ONE (One) received FDA 510(k) clearance on 2024-03-21, under 510(k) number K234081.

Who is the listed applicant for RedDrop ONE (One)?

The FDA 510(k) record lists Reddrop DX as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RedDrop ONE (One)?

The FDA product code for RedDrop ONE (One) is FMK.

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。

相关器械(代码:FMK)

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

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