FDA 510(k)

CIRRUS™ HD-OCT 型号 6000

K号: K233933 · 2024-05-17

决定日期2024-05-17

产品代码OBO

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

CIRRUS™ HD-OCT Model 6000 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 2024-05-17 under 510(k) number K233933. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CIRRUS™ HD-OCT Model 6000?

CIRRUS™ HD-OCT Model 6000 is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K233933.

When did CIRRUS™ HD-OCT Model 6000 receive FDA 510(k) clearance?

CIRRUS™ HD-OCT Model 6000 received FDA 510(k) clearance on 2024-05-17, under 510(k) number K233933.

Who is the listed applicant for CIRRUS™ HD-OCT Model 6000?

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 CIRRUS™ HD-OCT Model 6000?

The FDA product code for CIRRUS™ HD-OCT Model 6000 is OBO.

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)K230350VISULAS YAG K231075荧光配件（YELLOW 560 和 INFRARED 800 带FLOW 800 选项）K222200CIRRUS HD-OCT K191194CLARUS K181534CIRRUS HD-OCT

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。