Luna 4 plus
K号: K241102 · 2024-08-20
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器械摘要
Luna 4 plus is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K241102. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Luna 4 plus?
Luna 4 plus is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Foreo, Inc.. The 510(k) number is K241102.
When did Luna 4 plus receive FDA 510(k) clearance?
Luna 4 plus received FDA 510(k) clearance on 2024-08-20, under 510(k) number K241102.
Who is the listed applicant for Luna 4 plus?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Luna 4 plus?
The FDA product code for Luna 4 plus is OHS.
列明Foreo, Inc.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：OHS）
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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