MC 300* 喷雾器
K号: K173367 · 2018-02-28
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决定日期2018-02-28
产品代码CAF
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
MC 300* Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173367. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MC 300* Nebulizer?
MC 300* Nebulizer is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Trudell Medical International. The 510(k) number is K173367.
When did MC 300* Nebulizer receive FDA 510(k) clearance?
MC 300* Nebulizer received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173367.
Who is the listed applicant for MC 300* Nebulizer?
The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MC 300* Nebulizer?
The FDA product code for MC 300* Nebulizer is CAF.
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Trudell Medical International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：CAF）
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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