FDA 510(k)

LipiScan动态睑板腺成像仪

K号: K182506 · 2018-12-10

决定日期2018-12-10

产品代码HKI

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决定实质等同

器械摘要

LipiScan Dynamic Meibomian Imager is the device name listed in this FDA 510(k) record. The listed applicant is Tearscience, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K182506. 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 LipiScan Dynamic Meibomian Imager?

LipiScan Dynamic Meibomian Imager is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Tearscience, Inc.. The 510(k) number is K182506.

When did LipiScan Dynamic Meibomian Imager receive FDA 510(k) clearance?

LipiScan Dynamic Meibomian Imager received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182506.

Who is the listed applicant for LipiScan Dynamic Meibomian Imager?

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 LipiScan Dynamic Meibomian Imager?

The FDA product code for LipiScan Dynamic Meibomian Imager is HKI.

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。

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