FDA 510(k)

AirFit F30i 面罩系统；AirFit F30i NM 面罩系统；Arcadia 面罩系统

K号: K234134 · 2024-09-24

申请人Resmed Pty Ltd (Registration Number: 3004604967)

决定日期2024-09-24

产品代码BZD

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

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K234134. 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 F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K234134.

When did AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System receive FDA 510(k) clearance?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System received FDA 510(k) clearance on 2024-09-24, under 510(k) number K234134.

Who is the listed applicant for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

The FDA 510(k) record lists Resmed Pty Ltd (Registration Number: 3004604967) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

The FDA product code for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is BZD.

列明Resmed Pty Ltd (Registration Number: 3004604967)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。

K230476Oran Park 面罩 K223747惠特桑迪斯口罩系统

官方来源

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