FDA 510(k)

S10 Kirra

K号: K203126 · 2020-12-18

决定日期2020-12-18

产品代码BZD

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决定实质等同

器械摘要

S10 Kirra is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K203126. 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 S10 Kirra?

S10 Kirra is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K203126.

When did S10 Kirra receive FDA 510(k) clearance?

S10 Kirra received FDA 510(k) clearance on 2020-12-18, under 510(k) number K203126.

Who is the listed applicant for S10 Kirra?

The FDA 510(k) record lists Resmed Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S10 Kirra?

The FDA product code for S10 Kirra is BZD.

列明Resmed Pty , Ltd.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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