Grande医疗口罩，型号SF-600
K号: K232968 · 2024-06-06
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决定日期2024-06-06
产品代码FXX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Grande Medical Masks, Model SF-600 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Grande Corp.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K232968. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Grande Medical Masks, Model SF-600?
Grande Medical Masks, Model SF-600 is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Golden Grande Corp.. The 510(k) number is K232968.
When did Grande Medical Masks, Model SF-600 receive FDA 510(k) clearance?
Grande Medical Masks, Model SF-600 received FDA 510(k) clearance on 2024-06-06, under 510(k) number K232968.
Who is the listed applicant for Grande Medical Masks, Model SF-600?
The FDA 510(k) record lists Golden Grande Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Grande Medical Masks, Model SF-600?
The FDA product code for Grande Medical Masks, Model SF-600 is FXX.
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：FXX）
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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