SpotLight/SpotLight Duo（带DLIR选项）
K号: K230370 · 2023-10-13
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器械摘要
SpotLight/SpotLight Duo (with DLIR option) is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230370. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SpotLight/SpotLight Duo (with DLIR option)?
SpotLight/SpotLight Duo (with DLIR option) is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Arineta , Ltd.. The 510(k) number is K230370.
When did SpotLight/SpotLight Duo (with DLIR option) receive FDA 510(k) clearance?
SpotLight/SpotLight Duo (with DLIR option) received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230370.
Who is the listed applicant for SpotLight/SpotLight Duo (with DLIR option)?
The FDA 510(k) record lists Arineta , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpotLight/SpotLight Duo (with DLIR option)?
The FDA product code for SpotLight/SpotLight Duo (with DLIR option) is JAK.
相关临床试验
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列明Arineta , Ltd.为申报人的其他记录
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相关器械（代码：JAK）
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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