FDA 510(k)

Pentacam® 角膜OCT

K号: K251848 · 2026-03-13

决定日期2026-03-13

产品代码MXK

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决定实质等同

器械摘要

Pentacam® Cornea OCT is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgeräte GmbH. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251848. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pentacam® Cornea OCT?

Pentacam® Cornea OCT is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Oculus Optikgeräte GmbH. The 510(k) number is K251848.

When did Pentacam® Cornea OCT receive FDA 510(k) clearance?

Pentacam® Cornea OCT received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251848.

Who is the listed applicant for Pentacam® Cornea OCT?

The FDA 510(k) record lists Oculus Optikgeräte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pentacam® Cornea OCT?

The FDA product code for Pentacam® Cornea OCT is MXK.

列明Oculus Optikgeräte 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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