FDA 510(k)

Retina Workplace

K号: K182318 · 2018-10-24

决定日期2018-10-24

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

Retina Workplace is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K182318. 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 Retina Workplace?

Retina Workplace is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K182318.

When did Retina Workplace receive FDA 510(k) clearance?

Retina Workplace received FDA 510(k) clearance on 2018-10-24, under 510(k) number K182318.

Who is the listed applicant for Retina Workplace?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Retina Workplace?

The FDA product code for Retina Workplace is NFJ.

列明Carl Zeiss Meditec, 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。

K243878CLARUS (700)K233933CIRRUS™ HD-OCT 型号 6000 K230350VISULAS YAG K231075荧光配件（YELLOW 560 和 INFRARED 800 带FLOW 800 选项）K222200CIRRUS HD-OCT K191194CLARUS

查看所有 11 个设备 →

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。