FDA 510(k)

Spectralis HRA+OCT 和带有OCT血管造影模块的变体

K号: K181594 · 2018-09-13

决定日期2018-09-13

产品代码OBO

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决定实质等同

器械摘要

Spectralis HRA+OCT and variants with OCT Angiography 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 2018-09-13 under 510(k) number K181594. 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 with OCT Angiography Module?

Spectralis HRA+OCT and variants with OCT Angiography Module is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K181594.

When did Spectralis HRA+OCT and variants with OCT Angiography Module receive FDA 510(k) clearance?

Spectralis HRA+OCT and variants with OCT Angiography Module received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181594.

Who is the listed applicant for Spectralis HRA+OCT and variants with OCT Angiography 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 with OCT Angiography Module?

The FDA product code for Spectralis HRA+OCT and variants with OCT Angiography 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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