混合和输送系统
K号: K192674 · 2020-02-18
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决定日期2020-02-18
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
Mixing and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K192674. 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 Mixing and Delivery System?
Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K192674.
When did Mixing and Delivery System receive FDA 510(k) clearance?
Mixing and Delivery System received FDA 510(k) clearance on 2020-02-18, under 510(k) number K192674.
Who is the listed applicant for Mixing and Delivery System?
FDA 510(k)记录中列出Bone Solutions, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Mixing and Delivery System?
The FDA product code for Mixing and 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。
列明Bone Solutions, Inc.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：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
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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