FDA 510(k)

AirFit N20

K号: K171212 · 2017-09-28

决定日期2017-09-28

产品代码BZD

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决定实质等同

器械摘要

AirFit N20 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K171212. 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 AirFit N20?

AirFit N20 is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Resmed, Ltd.. The 510(k) number is K171212.

When did AirFit N20 receive FDA 510(k) clearance?

AirFit N20 received FDA 510(k) clearance on 2017-09-28, under 510(k) number K171212.

Who is the listed applicant for AirFit N20?

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

What is the FDA product code for AirFit N20?

The FDA product code for AirFit N20 is BZD.

列明Resmed, 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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