OdneClean
K号: K233844 · 2024-08-08
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申请人Odne AG
决定日期2024-08-08
产品代码ELC
咨询委员会DE
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决定实质等同
器械摘要
OdneClean is the device name listed in this FDA 510(k) record. The listed applicant is Odne AG. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233844. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OdneClean?
OdneClean is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Odne AG. The 510(k) number is K233844.
When did OdneClean receive FDA 510(k) clearance?
OdneClean received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233844.
Who is the listed applicant for OdneClean?
The FDA 510(k) record lists Odne AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OdneClean?
The FDA product code for OdneClean is ELC.
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相关器械（代码：ELC）
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
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