FDA 510(k)

F&P Evora全脸面罩

K号: K212371 · 2022-03-18

决定日期2022-03-18

产品代码BZD

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决定实质等同

器械摘要

F&P Evora Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K212371. 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 F&P Evora Full Face Mask?

F&P Evora Full Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212371.

When did F&P Evora Full Face Mask receive FDA 510(k) clearance?

F&P Evora Full Face Mask received FDA 510(k) clearance on 2022-03-18, under 510(k) number K212371.

Who is the listed applicant for F&P Evora Full Face Mask?

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

What is the FDA product code for F&P Evora Full Face Mask?

The FDA product code for F&P Evora Full Face Mask is BZD.

列明Fisher & Paykel Healthcare, 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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