MF SAFECATH
K号: K192230 · 2020-04-23
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决定日期2020-04-23
产品代码FOZ
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
MF SAFECATH is the device name listed in this FDA 510(k) record. The listed applicant is Medifirst Co., Ltd.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192230. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MF SAFECATH?
MF SAFECATH is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Medifirst Co., Ltd.. The 510(k) number is K192230.
When did MF SAFECATH receive FDA 510(k) clearance?
MF SAFECATH received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192230.
Who is the listed applicant for MF SAFECATH?
The FDA 510(k) record lists Medifirst Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MF SAFECATH?
The FDA product code for MF SAFECATH is FOZ.
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:FOZ)
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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