FDA 510(k)

SPECTRALIS带Flex模块

K号: K241163 · 2024-10-11

决定日期2024-10-11

产品代码OBO

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决定实质等同

器械摘要

SPECTRALIS with Flex Module is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K241163. 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 SPECTRALIS with Flex Module?

SPECTRALIS with Flex Module is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K241163.

When did SPECTRALIS with Flex Module receive FDA 510(k) clearance?

SPECTRALIS with Flex Module received FDA 510(k) clearance on 2024-10-11, under 510(k) number K241163.

Who is the listed applicant for SPECTRALIS with Flex Module?

FDA 510(k)记录列出了海德堡工程公司（Heidelberg Engineering GmbH）为申请人。这本身并不足以确定该设备的制造商。

What is the FDA product code for SPECTRALIS with Flex Module?

The FDA product code for SPECTRALIS with Flex Module is OBO.

列明Heidelberg Engineering GmbH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。

K261019安特里昂 K253837SPECTRALIS HRA+OCT及其变体；SPECTRALIS带Flex模块 K250868SPECTRALIS HRA+OCT及其变体 K240924Anterion K240221SPECTRALIS HRA+OCT及其变体 K223557SPECTRALIS HRA+OCT及其变体

查看所有 16 个设备 →

官方来源

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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。