NavaClick Injection System
K号: K231877 · 2023-11-30
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决定日期2023-11-30
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。
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器械摘要
NavaClick Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Lineage Biomedical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K231877. 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 NavaClick Injection System?
NavaClick Injection System is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Lineage Biomedical, Inc.. The 510(k) number is K231877.
When did NavaClick Injection System receive FDA 510(k) clearance?
NavaClick Injection System received FDA 510(k) clearance on 2023-11-30, under 510(k) number K231877.
Who is the listed applicant for NavaClick Injection System?
The FDA 510(k) record lists Lineage Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NavaClick Injection System?
The FDA product code for NavaClick Injection System is FMF.
相关临床试验
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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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