呼吸回路细菌/病毒过滤器
K号: K222917 · 2024-02-15
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决定日期2024-02-15
产品代码CAH
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
Breathing circuit bacterial/viral filter is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K222917. 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 Breathing circuit bacterial/viral filter?
Breathing circuit bacterial/viral filter is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. The 510(k) number is K222917.
When did Breathing circuit bacterial/viral filter receive FDA 510(k) clearance?
Breathing circuit bacterial/viral filter received FDA 510(k) clearance on 2024-02-15, under 510(k) number K222917.
Who is the listed applicant for Breathing circuit bacterial/viral filter?
The FDA 510(k) record lists Shaoxing Haitech Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breathing circuit bacterial/viral filter?
The FDA product code for Breathing circuit bacterial/viral filter 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。
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/SK241339Besmed 细菌过滤器和高流量湿化器Besmed Health Business CorpK230483Passy 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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