FDA 510(k)

SPECTRALIS HRA+OCT及其变体；SPECTRALIS带Flex模块

K号: K253837 · 2026-05-07

决定日期2026-05-07

产品代码OBO

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决定实质等同

器械摘要

SPECTRALIS HRA+OCT and variants; 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 2026-05-07 under 510(k) number K253837. 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 HRA+OCT and variants; SPECTRALIS with Flex Module?

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K253837.

When did SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module receive FDA 510(k) clearance?

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253837.

Who is the listed applicant for SPECTRALIS HRA+OCT and variants; 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 HRA+OCT and variants; SPECTRALIS with Flex Module?

The FDA product code for SPECTRALIS HRA+OCT and variants; 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。

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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。