SAFIRA
K号: K230083 · 2023-10-31
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决定日期2023-10-31
产品代码FRN
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
SAFIRA is the device name listed in this FDA 510(k) record. The listed applicant is Medovate Limited. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K230083. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SAFIRA?
SAFIRA is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Medovate Limited. The 510(k) number is K230083.
When did SAFIRA receive FDA 510(k) clearance?
SAFIRA received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230083.
Who is the listed applicant for SAFIRA?
The FDA 510(k) record lists Medovate Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SAFIRA?
The FDA product code for SAFIRA is FRN.
相关临床试验
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相关器械（代码：FRN）
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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