一次性手术口罩（型号：YYKZ-01）
K号: K210845 · 2021-10-12
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决定日期2021-10-12
产品代码FXX
咨询委员会SU
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决定实质等同
器械摘要
Disposable Surgical Mask (Model: YYKZ-01) is the device name listed in this FDA 510(k) record. The listed applicant is Jiaxing Amazing Travel-Ware Co., Ltd.. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K210845. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Disposable Surgical Mask (Model: YYKZ-01)?
Disposable Surgical Mask (Model: YYKZ-01) is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Jiaxing Amazing Travel-Ware Co., Ltd.. The 510(k) number is K210845.
When did Disposable Surgical Mask (Model: YYKZ-01) receive FDA 510(k) clearance?
Disposable Surgical Mask (Model: YYKZ-01) received FDA 510(k) clearance on 2021-10-12, under 510(k) number K210845.
Who is the listed applicant for Disposable Surgical Mask (Model: YYKZ-01)?
The FDA 510(k) record lists Jiaxing Amazing Travel-Ware Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Surgical Mask (Model: YYKZ-01)?
The FDA product code for Disposable Surgical Mask (Model: YYKZ-01) is FXX.
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：FXX）
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。
K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.
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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