FDA 510(k)

OptosAdvance 4.0 软件

K号: K162039 · 2017-02-08

决定日期2017-02-08

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

OptosAdvance 4.0 Software is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K162039. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OptosAdvance 4.0 Software?

OptosAdvance 4.0 Software is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Optos Plc.. The 510(k) number is K162039.

When did OptosAdvance 4.0 Software receive FDA 510(k) clearance?

OptosAdvance 4.0 Software received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162039.

Who is the listed applicant for OptosAdvance 4.0 Software?

The FDA 510(k) record lists Optos Plc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptosAdvance 4.0 Software?

The FDA product code for OptosAdvance 4.0 Software is NFJ.

列明Optos Plc.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。

K233602P200TE（A10700）K231673P200TE（A10700）K190732P200TxE K173707P200TE

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