Besmed 细菌过滤器和高流量湿化器
K号: K241339 · 2024-11-14
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决定日期2024-11-14
产品代码CAH
咨询委员会AN
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决定实质等同
器械摘要
Besmed Bacterial Filter and HMEF is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K241339. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Besmed Bacterial Filter and HMEF?
Besmed Bacterial Filter and HMEF is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Besmed Health Business Corp. The 510(k) number is K241339.
When did Besmed Bacterial Filter and HMEF receive FDA 510(k) clearance?
Besmed Bacterial Filter and HMEF received FDA 510(k) clearance on 2024-11-14, under 510(k) number K241339.
Who is the listed applicant for Besmed Bacterial Filter and HMEF?
The FDA 510(k) record lists Besmed Health Business Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Besmed Bacterial Filter and HMEF?
The FDA product code for Besmed Bacterial Filter and HMEF is CAH.
相关临床试验
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。
列明Besmed Health Business Corp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：CAH）
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。
K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® 呼气过滤器Ambu A/SK222917呼吸回路细菌/病毒过滤器Shaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir 气管切开术病毒和细菌气道保护过滤器（PM-APF15）Passy-Muir, Inc.K223258TNI Clear-Guard® 3角位呼吸过滤器（1545020）Intersurgical , Ltd.K221472Filter 和 HME/FilterNingbo Huakun Medical Equipment Co., Ltd.
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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