AAMI级别4防护服
K号: K222128 · 2023-08-08
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决定日期2023-08-08
产品代码QPC
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
Protective Gown AAMI Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K222128. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Protective Gown AAMI Level 4?
Protective Gown AAMI Level 4 is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Kenpax International Limited. The 510(k) number is K222128.
When did Protective Gown AAMI Level 4 receive FDA 510(k) clearance?
Protective Gown AAMI Level 4 received FDA 510(k) clearance on 2023-08-08, under 510(k) number K222128.
Who is the listed applicant for Protective Gown AAMI Level 4?
The FDA 510(k) record lists Kenpax International Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Protective Gown AAMI Level 4?
The FDA product code for Protective Gown AAMI Level 4 is QPC.
相关临床试验
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列明Kenpax International Limited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：QPC）
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。
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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