FDA 510(k)

Altis Full Face Mask

K号: K261262 · 2026-09-25

决定日期2026-09-25

产品代码BZD

咨询委员会AN

决定Substantially Equivalent

器械摘要

Altis Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261262. 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 Altis Full Face Mask?

Altis Full Face Mask is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Respironics, Inc.. The 510(k) number is K261262.

When did Altis Full Face Mask receive FDA 510(k) clearance?

Altis Full Face Mask received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261262.

Who is the listed applicant for Altis Full Face Mask?

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

What is the FDA product code for Altis Full Face Mask?

The FDA product code for Altis Full Face Mask is BZD.

列明Respironics, Inc.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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