FDA 510(k)

AirLife® 开放式氧疗面罩，AirLife® 开放式氧疗面罩+

K号: K230915 · 2024-11-12

决定日期2024-11-12

产品代码CCK

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

AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K230915. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask?

AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K230915.

When did AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask receive FDA 510(k) clearance?

AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask received FDA 510(k) clearance on 2024-11-12, under 510(k) number K230915.

Who is the listed applicant for AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask?

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

What is the FDA product code for AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask?

The FDA product code for AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask is CCK.

列明Vyaire Medical, 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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