Clicky 十字
K号: K210516 · 2022-05-16
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决定日期2022-05-16
产品代码FMG
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
Clicky Cross is the device name listed in this FDA 510(k) record. The listed applicant is Yomura Technologies, Inc.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K210516. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Clicky Cross?
Clicky Cross is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Yomura Technologies, Inc.. The 510(k) number is K210516.
When did Clicky Cross receive FDA 510(k) clearance?
Clicky Cross received FDA 510(k) clearance on 2022-05-16, under 510(k) number K210516.
Who is the listed applicant for Clicky Cross?
The FDA 510(k) record lists Yomura Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clicky Cross?
The FDA product code for Clicky Cross is FMG.
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：FMG）
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。
K242255Qitexio® 4路旋塞（QIT014）MedexK223499三通截止阀M/S Romsons InternationalK223175腔内给药套装，带旋塞和歧管Baxter Healthcare CorporationK211204SafePort™ 多路阀（或旋塞）Elcam Medical AcalK190539TurnSignal 止血夹无菌，TurnSignal 止血夹非无菌，TurnSignal 配有歧管的止血夹无菌，TurnSignal 配有歧管的止血夹非无菌Monumedical, LLCK190489Elcam 停止阀和歧管Elcam Medical Acal
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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