FDA 510(k)

Spectralis HRA + OCT and variants

K号: K173648 · 2018-08-30

决定日期2018-08-30

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 2018-08-30 under 510(k) number K173648. 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 2018-08-30. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K173648.

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

Spectralis HRA + OCT and variants received FDA 510(k) clearance on 2018-08-30, under 510(k) number K173648.

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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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。