TNI Clear-Guard® 3角位呼吸过滤器（1545020）
K号: K223258 · 2023-06-15
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决定日期2023-06-15
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
TNI Clear-Guard™ 3 angled breathing filter (1545020) is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223258. 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 TNI Clear-Guard™ 3 angled breathing filter (1545020)?
TNI Clear-Guard™ 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Intersurgical , Ltd.. The 510(k) number is K223258.
When did TNI Clear-Guard™ 3 angled breathing filter (1545020) receive FDA 510(k) clearance?
TNI Clear-Guard™ 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223258.
Who is the listed applicant for TNI Clear-Guard™ 3 angled breathing filter (1545020)?
The FDA 510(k) record lists Intersurgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020)?
The FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020) is CAH.
相关临床试验
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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。
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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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