FDA 510(k)

Spectralis HRA+OCT and Variants

K号: K192391 · 2019-09-26

决定日期2019-09-26

产品代码OBO

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决定实质等同

器械摘要

Spectralis HRA+OCT and Variants 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 2019-09-26 under 510(k) number K192391. 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 HRA+OCT and Variants is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K192391.

When did Spectralis HRA+OCT and Variants receive FDA 510(k) clearance?

Spectralis HRA+OCT and Variants received FDA 510(k) clearance on 2019-09-26, under 510(k) number K192391.

Who is the listed applicant for Spectralis HRA+OCT and Variants?

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?

The FDA product code for Spectralis HRA+OCT and Variants 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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