Oran Park 面罩
K号: K230476 · 2023-10-19
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决定日期2023-10-19
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
Oran Park Mask 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 2023-10-19 under 510(k) number K230476. 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 Oran Park Mask?
Oran Park Mask is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K230476.
When did Oran Park Mask receive FDA 510(k) clearance?
Oran Park Mask received FDA 510(k) clearance on 2023-10-19, under 510(k) number K230476.
Who is the listed applicant for Oran Park Mask?
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 Oran Park Mask?
The FDA product code for Oran Park Mask 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。
相关器械（代码：BZD）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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