Zilia 眼科 FC（ZIL-10002）
K号: K230627 · 2023-11-20
广告
申请人Zilia, Inc.
决定日期2023-11-20
产品代码HKI
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Zilia Ocular FC (ZIL-10002) is the device name listed in this FDA 510(k) record. The listed applicant is Zilia, Inc.. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K230627. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Zilia Ocular FC (ZIL-10002)?
Zilia Ocular FC (ZIL-10002) is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is Zilia, Inc.. The 510(k) number is K230627.
When did Zilia Ocular FC (ZIL-10002) receive FDA 510(k) clearance?
Zilia Ocular FC (ZIL-10002) received FDA 510(k) clearance on 2023-11-20, under 510(k) number K230627.
Who is the listed applicant for Zilia Ocular FC (ZIL-10002)?
The FDA 510(k) record lists Zilia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zilia Ocular FC (ZIL-10002)?
The FDA product code for Zilia Ocular FC (ZIL-10002) is HKI.
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：HKI）
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。
广告