NightOwl
K号: K213463 · 2021-12-16
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申请人Ectosense NV
决定日期2021-12-16
产品代码MNR
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
NightOwl is the device name listed in this FDA 510(k) record. The listed applicant is Ectosense NV. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213463. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NightOwl?
NightOwl is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ectosense NV. The 510(k) number is K213463.
When did NightOwl receive FDA 510(k) clearance?
NightOwl received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213463.
Who is the listed applicant for NightOwl?
The FDA 510(k) record lists Ectosense NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NightOwl?
The FDA product code for NightOwl is MNR.
相关临床试验
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列明Ectosense NV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：MNR）
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
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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