PreferX 配送系统
K号: K210997 · 2021-09-07
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申请人Md3, LLC
决定日期2021-09-07
产品代码FMF
咨询委员会医疗设备监管文本翻译如下:
HO
请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
PreferX Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Md3, LLC. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K210997. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PreferX Delivery System?
PreferX Delivery System is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Md3, LLC. The 510(k) number is K210997.
When did PreferX Delivery System receive FDA 510(k) clearance?
PreferX Delivery System received FDA 510(k) clearance on 2021-09-07, under 510(k) number K210997.
Who is the listed applicant for PreferX Delivery System?
The FDA 510(k) record lists Md3, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreferX Delivery System?
The FDA product code for PreferX Delivery System is FMF.
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:FMF)
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
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