FDA 510(k)

Orion

K号: K253553 · 2026-06-04

决定日期2026-06-04

产品代码BZD

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Orion is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253553. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Orion?

Orion is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Resmed Corp. The 510(k) number is K253553.

When did Orion receive FDA 510(k) clearance?

Orion received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253553.

Who is the listed applicant for Orion?

FDA 510(k)记录显示Resmed Corp为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Orion?

The FDA product code for Orion is BZD.

列明Resmed Corp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。

K261360EasyCare Tx 2 K254104ResScan 基础版 K251889我的空气 K251657个性化治疗舒适设置（PTCS）K250624我的空气 K241939EasyCare Tx 2

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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。