LipiView II 眼表干涉仪
K号: K152869 · 2016-01-14
广告
决定日期2016-01-14
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
LipiView II Ocular Surface Interferometer is the device name listed in this FDA 510(k) record. The listed applicant is Tearscience, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152869. 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 LipiView II Ocular Surface Interferometer?
LipiView II Ocular Surface Interferometer is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Tearscience, Inc.. The 510(k) number is K152869.
When did LipiView II Ocular Surface Interferometer receive FDA 510(k) clearance?
LipiView II Ocular Surface Interferometer received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152869.
Who is the listed applicant for LipiView II Ocular Surface Interferometer?
The FDA 510(k) record lists Tearscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LipiView II Ocular Surface Interferometer?
The FDA product code for LipiView II Ocular Surface Interferometer 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。
列明Tearscience, 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：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