ROKI外科口罩
K号: K214094 · 2022-02-24
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器械摘要
ROKI Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Roki Co., Ltd.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K214094. 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 ROKI Surgical Mask?
ROKI Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Roki Co., Ltd.. The 510(k) number is K214094.
When did ROKI Surgical Mask receive FDA 510(k) clearance?
ROKI Surgical Mask received FDA 510(k) clearance on 2022-02-24, under 510(k) number K214094.
Who is the listed applicant for ROKI Surgical Mask?
The FDA 510(k) record lists Roki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROKI Surgical Mask?
The FDA product code for ROKI Surgical Mask 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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